Facial Rhytidectomy (Face-lift)
Conditions
Brief summary
The primary objective of this study is to evaluate the efficacy and safety of fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated (FS VH S/D 4) when used to reduce early postoperative bruising in participants undergoing a rhytidectomy (face-lift).
Interventions
BIOLOGICALFibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)
Each subject received fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated containing synthetic aprotinin (FS VH S/D 4 ) to one side of the face. The dosing volume to be applied is 0.02 mL/cm2 to 0.04 mL/cm2. The study product will be applied to the subcutaneous plane in both the neck and the face area. The product will be applied using the spray device provided by the sponsor. (The other side of the face will be treated using standard of care.)
Sponsors
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects planned for facial rhytidectomy * Subjects who read, understand and sign the written informed consent * Healthy female or male subjects as determined by the investigator using standard pre-operative assessments to include laboratory tests and ECG * Subjects 18-75 years old, inclusively * Subjects who are able and willing to comply with the protocol requirements * Female subjects of childbearing potential with a negative urine or serum pregnancy test within 72 hours of surgery
Exclusion criteria
* Pregnant or lactating women * Subjects who have undergone previous face-lift surgery * Subjects undergoing abbreviated face-lift procedures such as deep plane procedures, minimal undermining procedures, thread lifts, and minimal access cranial suspension * Subjects indicated for concurrent facial surgeries during the operation (e.g. forehead plasty, blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.) * Subjects indicated for additional procedures during the same operation (e.g., liposuction, mastoplasty etc.) * Subjects who had prior silicone injections to their face (Botox and/or Restylane are allowed) * Subjects considered by the investigator to be smokers * Subjects with ecchymosis and/or edema on the face on day 0, prior to surgery * Subjects with known (documented) bleeding or coagulation disorders * Subjects currently being treated with anti-coagulants * Subjects treated with Aspirin in the last 7 days or use of other Non-steroidal anti-inflammatory drug (NSAIDs) within the last 7 days prior to surgery * Subjects with vascular disorders, cardiovascular disease, and/or uncontrolled hypertension * Subjects with diabetes mellitus * Subjects with a history of Bell´s palsy * Subjects with connective tissue disorders * Subjects with documented history of pathologically or pharmacologically induced immune deficiency * Subjects receiving systemic corticosteroid treatment for a chronic condition within 2 to 30 days prior to the surgery * Subjects with a known sensitivity to fibrin sealants * Subjects with a known psychiatric disorder (e.g., depression, obsessive compulsive disorder, anxiety, eating disorders, etc) * Subjects who have participated in another clinical study within 30 days prior to this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Comparison of Ecchymosis at Postoperative Day 3 | Through Postoperative Day 3 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. |
| Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period | Through Postoperative Day 14 (± 1) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Comparison of Ecchymosis at Day 7 | Through Postoperative Day 7 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. |
| Visual Comparison of Ecchymosis at Day 10 | Through Postoperative Day 10 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. |
| Visual Comparison of Ecchymosis at Day 14 | Through Postoperative Day 14 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. |
| Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 1 | Through Postoperative Day 1 | Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved Statistical Analysis Plan (SAP) specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 3 | Through Postoperative Day 3 | Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 5 | Through Postoperative Day 5 | Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 7 | Through Postoperative Day 7 | Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 10 | Through Postoperative Day 10 | Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 14 | Through Postoperative Day 14 | Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by a Blinded On-site Evaluator-Day 3 | Postoperative Day 3 | Difference between each side of the face are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1 | Through Postoperative Day 1 | Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil, Grade 2= Minor, Grade 3= Moderate, Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3 | Through Postoperative Day 3 | Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5 | Through Postoperative Day 5 | Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7 | Through Postoperative Day 7 | Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10 | Through Postoperative Day 10 | Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Visual Comparison of Ecchymosis at Day 1 | Through Postoperative Day 1 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. |
| Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1 | Through Postoperative Day 1 | Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3 | Through Postoperative Day 3 | Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5 | Through Postoperative Day 5 | Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7 | Through Postoperative Day 7 | Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10 | Through Postoperative Day 10 | Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14 | Through Postoperative Day 14 | Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Resolution of Ecchymosis as Assessed by Investigators | Postoperative Days 1, 3, 5, 7, 10, and 14 | Resolution of ecchymosis (grade 0 on the Modified Marchac Scale for ecchymosis (Grade 0 = No bruising at all)) |
| Resolution of Edema as Assessed by Investigators. | Postoperative Days 1, 3, 5, 7, 10, and 14 | Resolution of edema (grade 1 on the Marchac Scale for Edema (Grade 1 = Nil) |
| Total Volume of Drainage on Each Side of the Face | 24 hours postoperative | — |
| Participants With Hematoma/Seroma | Days 0, 1, 3, 5, 7,10, and 14 | Investigators assessed each side of the face for the presence of hematoma/seroma |
| Participants With Hematoma/Seroma During the Study | Through Postoperative Day 14 (± 1) | Investigators assessed each side of the face for the presence of hematoma/seroma |
| Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14 | Postoperative Days 3, 7, 10, and 14 | Two-point discrimination test performed by investigators to assess nerve regeneration. Testing performed on each side of the face (SoC and FS VH S/D 4). Differences are calculated as: Postoperative Day - Day 0, reported as minimal distance at which participants were able to discern feeling at two distinct points |
| Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4) | Days 1, 3, 5, 7,10, and 14 | Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a pain assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the pain experienced, i.e. 10 = worst, 1 = least. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4) | Days 1, 3, 5, 7,10, and 14 | Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a numbness assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the numbness experienced, i.e. 10 = worst, 1 = least. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Postoperative Days 1, 3, 5, 7, 10, and 14 | Participants compared the levels of bruising on each side of their face and determine if they had a preference for the look of 1 side over another. |
| Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14 | Through Postoperative Day 14 | Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Visual Comparison of Ecchymosis at Day 5 | Through Postoperative Day 5 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled at 6 clinical sites in the United States, beginning June 2008 and completing in September 2008
Pre-assignment details
56 participants were enrolled and screened. 2 were screen failures. 9 were withdrawn prior to randomization (1 due to untoward medical occurrence, 2 due to study site over enrollment, 2 requested withdrawal, 2 had scheduling conflicts, 1 had surgery delayed, 1 missed deadline for enrollment. Therefore, 45 of the 56 enrolled were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Facelift Participants One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care. | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Facelift Participants |
|---|---|
| Age Continuous | 55.1 years STANDARD_DEVIATION 6.9 |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 45 | 3 / 45 | 0 / 45 |
| serious Total, serious adverse events | 1 / 45 | 0 / 45 | 0 / 45 |
Outcome results
Primary
Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period
Time frame: Through Postoperative Day 14 (± 1)
Population: Safety Data Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period | 0 Adverse Events |
Primary
Visual Comparison of Ecchymosis at Postoperative Day 3
Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.
Time frame: Through Postoperative Day 3
Population: Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Visual Comparison of Ecchymosis at Postoperative Day 3 | 5 participants |
| Participants With Less Ecchymosis Treated With SoC | Visual Comparison of Ecchymosis at Postoperative Day 3 | 12 participants |
| Participants With Equal Ecchymosis On Both Sides | Visual Comparison of Ecchymosis at Postoperative Day 3 | 11 participants |
| Participants With No Ecchymosis on Either Side | Visual Comparison of Ecchymosis at Postoperative Day 3 | 0 participants |
p-value: 0.14395% CI: [-0.04, 0.49]McNemar
Secondary
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1
Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil, Grade 2= Minor, Grade 3= Moderate, Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 1
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1 | 0.00 Scores on a scale |
p-value: 0.754Two-sided Wilcoxon paired sample tests
Secondary
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10
Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 10
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10 | 0.0 Scores on a scale |
p-value: 0.625Two-sided Wilcoxon paired sample tests
Secondary
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14
Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 14
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14 | 0.0 Scores on a scale |
p-value: 0.688Two-sided Wilcoxon paired sample tests
Secondary
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3
Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 3
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3 | 0.0 Scores on a scale |
p-value: 0.388Two-sided Wilcoxon paired sample tests
Secondary
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5
Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 5
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5 | 0.0 Scores on a scale |
p-value: 0.234Two-sided Wilcoxon paired sample tests
Secondary
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7
Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 7
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7 | 0.0 Scores on a scale |
p-value: 0.688Two-sided Wilcoxon paired sample tests
Secondary
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 1
Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved Statistical Analysis Plan (SAP) specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 1
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 1 | 0.0 Scores on a scale |
p-value: 0.645Two-sided Wilcoxon paired sample tests
Secondary
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 10
Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 10
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 10 | 0.0 Scores on a scale |
p-value: 0.247Two-sided Wilcoxon paired sample tests
Secondary
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 14
Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 14
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 14 | 0.0 Scores on a scale |
p-value: 0.715Two-sided Wilcoxon paired sample tests
Secondary
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 3
Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 3
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 3 | -0.2 Scores on a scale |
p-value: 0.103Two-sided Wilcoxon paired sample tests
Secondary
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 5
Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 5
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 5 | 0.0 Scores on a scale |
p-value: 0.833Two-sided Wilcoxon paired sample tests
Secondary
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 7
Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 7
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 7 | 0.0 Scores on a scale |
p-value: 0.501Two-sided Wilcoxon paired sample tests
Secondary
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by a Blinded On-site Evaluator-Day 3
Difference between each side of the face are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Postoperative Day 3
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by a Blinded On-site Evaluator-Day 3 | 0.00 Scores on a scale |
Secondary
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1
Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 1
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1 | 0.0 Scores on a scale |
p-value: 1Two-sided Wilcoxon paired sample tests
Secondary
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10
Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 10
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10 | 0.0 Scores on a scale |
p-value: 1Two-sided Wilcoxon paired sample tests
Secondary
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14
Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 14
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14 | 0.0 Scores on a scale |
p-value: 0.699Two-sided Wilcoxon paired sample tests
Secondary
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3
Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 3
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3 | 0.0 Scores on a scale |
p-value: 0.521Two-sided Wilcoxon paired sample tests
Secondary
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5
Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 5
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5 | 0.0 Scores on a scale |
p-value: 0.324Two-sided Wilcoxon paired sample tests
Secondary
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7
Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Through Postoperative Day 7
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7 | 0.0 Scores on a scale |
p-value: 0.661Two-sided Wilcoxon paired sample tests
Secondary
Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14
Two-point discrimination test performed by investigators to assess nerve regeneration. Testing performed on each side of the face (SoC and FS VH S/D 4). Differences are calculated as: Postoperative Day - Day 0, reported as minimal distance at which participants were able to discern feeling at two distinct points
Time frame: Postoperative Days 3, 7, 10, and 14
Population: Per protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14 | 7 mm |
| Participants With Less Ecchymosis Treated With SoC | Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14 | 7 mm |
| Participants With Equal Ecchymosis On Both Sides | Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14 | 5 mm |
| Participants With No Ecchymosis on Either Side | Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14 | 6 mm |
| FS VH S/D 4 - Day 10 | Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14 | 5 mm |
| SoC - Day 10 | Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14 | 5 mm |
| FS VH S/D 4 - Day 14 | Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14 | 0 mm |
| SoC - Day 14 | Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14 | 5 mm |
Secondary
Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4)
Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a numbness assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the numbness experienced, i.e. 10 = worst, 1 = least. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Days 1, 3, 5, 7,10, and 14
Population: Per Protocol
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4) | Day 1 | 0 Scores on a scale |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4) | Day 3 | 0 Scores on a scale |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4) | Day 5 | 0 Scores on a scale |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4) | Day 7 | 0 Scores on a scale |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4) | Day 10 | 0 Scores on a scale |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4) | Day 14 | 0 Scores on a scale |
Secondary
Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4)
Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a pain assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the pain experienced, i.e. 10 = worst, 1 = least. The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Time frame: Days 1, 3, 5, 7,10, and 14
Population: Per Protocol
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4) | Day 1 | 0 Scores on a scale |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4) | Day 3 | 0 Scores on a scale |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4) | Day 5 | 0 Scores on a scale |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4) | Day 7 | 0 Scores on a scale |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4) | Day 10 | 0 Scores on a scale |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4) | Day 14 | 0 Scores on a scale |
Secondary
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4)
Participants compared the levels of bruising on each side of their face and determine if they had a preference for the look of 1 side over another.
Time frame: Postoperative Days 1, 3, 5, 7, 10, and 14
Population: Per Protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 1 | 5 participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 3 | 1 participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 5 | 2 participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 7 | 2 participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 10 | 5 participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 14 | 5 participants |
| Participants With Less Ecchymosis Treated With SoC | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 14 | 12 participants |
| Participants With Less Ecchymosis Treated With SoC | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 1 | 12 participants |
| Participants With Less Ecchymosis Treated With SoC | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 7 | 17 participants |
| Participants With Less Ecchymosis Treated With SoC | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 10 | 13 participants |
| Participants With Less Ecchymosis Treated With SoC | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 3 | 20 participants |
| Participants With Less Ecchymosis Treated With SoC | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 5 | 17 participants |
| Participants With Equal Ecchymosis On Both Sides | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 3 | 12 participants |
| Participants With Equal Ecchymosis On Both Sides | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 5 | 14 participants |
| Participants With Equal Ecchymosis On Both Sides | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 14 | 15 participants |
| Participants With Equal Ecchymosis On Both Sides | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 7 | 14 participants |
| Participants With Equal Ecchymosis On Both Sides | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 1 | 16 participants |
| Participants With Equal Ecchymosis On Both Sides | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) | Day 10 | 15 participants |
Secondary
Participants With Hematoma/Seroma
Investigators assessed each side of the face for the presence of hematoma/seroma
Time frame: Days 0, 1, 3, 5, 7,10, and 14
Population: Per Protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Participants With Hematoma/Seroma | Day 3 | 2 Participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Participants With Hematoma/Seroma | Day 7 | 1 Participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Participants With Hematoma/Seroma | Day 1 | 1 Participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Participants With Hematoma/Seroma | Day 10 | 2 Participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Participants With Hematoma/Seroma | Day 5 | 1 Participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Participants With Hematoma/Seroma | Day 14 | 1 Participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Participants With Hematoma/Seroma | Day 0 | 2 Participants |
| Participants With Less Ecchymosis Treated With SoC | Participants With Hematoma/Seroma | Day 14 | 0 Participants |
| Participants With Less Ecchymosis Treated With SoC | Participants With Hematoma/Seroma | Day 0 | 0 Participants |
| Participants With Less Ecchymosis Treated With SoC | Participants With Hematoma/Seroma | Day 1 | 0 Participants |
| Participants With Less Ecchymosis Treated With SoC | Participants With Hematoma/Seroma | Day 3 | 0 Participants |
| Participants With Less Ecchymosis Treated With SoC | Participants With Hematoma/Seroma | Day 5 | 0 Participants |
| Participants With Less Ecchymosis Treated With SoC | Participants With Hematoma/Seroma | Day 7 | 0 Participants |
| Participants With Less Ecchymosis Treated With SoC | Participants With Hematoma/Seroma | Day 10 | 0 Participants |
Secondary
Participants With Hematoma/Seroma During the Study
Investigators assessed each side of the face for the presence of hematoma/seroma
Time frame: Through Postoperative Day 14 (± 1)
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Participants With Hematoma/Seroma During the Study | 0 participants |
| Participants With Less Ecchymosis Treated With SoC | Participants With Hematoma/Seroma During the Study | 6 participants |
| Participants With Equal Ecchymosis On Both Sides | Participants With Hematoma/Seroma During the Study | 0 participants |
| Participants With No Ecchymosis on Either Side | Participants With Hematoma/Seroma During the Study | 27 participants |
p-value: 0.01495% CI: [0.04, 0.34]McNemar's test of paired proportions
Secondary
Resolution of Ecchymosis as Assessed by Investigators
Resolution of ecchymosis (grade 0 on the Modified Marchac Scale for ecchymosis (Grade 0 = No bruising at all))
Time frame: Postoperative Days 1, 3, 5, 7, 10, and 14
Population: Per Protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Resolution of Ecchymosis as Assessed by Investigators | By Day 1 | 0 participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Resolution of Ecchymosis as Assessed by Investigators | By Day 3 | 0 participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Resolution of Ecchymosis as Assessed by Investigators | By Day 5 | 1 participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Resolution of Ecchymosis as Assessed by Investigators | By Day 7 | 1 participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Resolution of Ecchymosis as Assessed by Investigators | By Day 10 | 1 participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Resolution of Ecchymosis as Assessed by Investigators | By Day 14 | 1 participants |
| Participants With Less Ecchymosis Treated With SoC | Resolution of Ecchymosis as Assessed by Investigators | By Day 14 | 3 participants |
| Participants With Less Ecchymosis Treated With SoC | Resolution of Ecchymosis as Assessed by Investigators | By Day 7 | 0 participants |
| Participants With Less Ecchymosis Treated With SoC | Resolution of Ecchymosis as Assessed by Investigators | By Day 1 | 0 participants |
| Participants With Less Ecchymosis Treated With SoC | Resolution of Ecchymosis as Assessed by Investigators | By Day 5 | 0 participants |
| Participants With Less Ecchymosis Treated With SoC | Resolution of Ecchymosis as Assessed by Investigators | By Day 3 | 0 participants |
| Participants With Less Ecchymosis Treated With SoC | Resolution of Ecchymosis as Assessed by Investigators | By Day 10 | 0 participants |
| Participants With Equal Ecchymosis On Both Sides | Resolution of Ecchymosis as Assessed by Investigators | By Day 3 | 1 participants |
| Participants With Equal Ecchymosis On Both Sides | Resolution of Ecchymosis as Assessed by Investigators | By Day 5 | 0 participants |
| Participants With Equal Ecchymosis On Both Sides | Resolution of Ecchymosis as Assessed by Investigators | By Day 7 | 0 participants |
| Participants With Equal Ecchymosis On Both Sides | Resolution of Ecchymosis as Assessed by Investigators | By Day 14 | 7 participants |
| Participants With Equal Ecchymosis On Both Sides | Resolution of Ecchymosis as Assessed by Investigators | By Day 10 | 1 participants |
| Participants With Equal Ecchymosis On Both Sides | Resolution of Ecchymosis as Assessed by Investigators | By Day 1 | 2 participants |
| Participants With No Ecchymosis on Either Side | Resolution of Ecchymosis as Assessed by Investigators | By Day 10 | 31 participants |
| Participants With No Ecchymosis on Either Side | Resolution of Ecchymosis as Assessed by Investigators | By Day 14 | 22 participants |
| Participants With No Ecchymosis on Either Side | Resolution of Ecchymosis as Assessed by Investigators | By Day 3 | 32 participants |
| Participants With No Ecchymosis on Either Side | Resolution of Ecchymosis as Assessed by Investigators | By Day 7 | 32 participants |
| Participants With No Ecchymosis on Either Side | Resolution of Ecchymosis as Assessed by Investigators | By Day 1 | 31 participants |
| Participants With No Ecchymosis on Either Side | Resolution of Ecchymosis as Assessed by Investigators | By Day 5 | 32 participants |
Secondary
Resolution of Edema as Assessed by Investigators.
Resolution of edema (grade 1 on the Marchac Scale for Edema (Grade 1 = Nil)
Time frame: Postoperative Days 1, 3, 5, 7, 10, and 14
Population: Per Protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Resolution of Edema as Assessed by Investigators. | By Day 1 (n=32) | 3 participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Resolution of Edema as Assessed by Investigators. | By Day 3 (n=33) | 0 participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Resolution of Edema as Assessed by Investigators. | By Day 5 (n=33) | 0 participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Resolution of Edema as Assessed by Investigators. | By Day 7 (n=33) | 1 participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Resolution of Edema as Assessed by Investigators. | By Day 10 (n=32) | 1 participants |
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Resolution of Edema as Assessed by Investigators. | By Day 14 (n=32) | 4 participants |
| Participants With Less Ecchymosis Treated With SoC | Resolution of Edema as Assessed by Investigators. | By Day 14 (n=32) | 2 participants |
| Participants With Less Ecchymosis Treated With SoC | Resolution of Edema as Assessed by Investigators. | By Day 7 (n=33) | 0 participants |
| Participants With Less Ecchymosis Treated With SoC | Resolution of Edema as Assessed by Investigators. | By Day 1 (n=32) | 0 participants |
| Participants With Less Ecchymosis Treated With SoC | Resolution of Edema as Assessed by Investigators. | By Day 5 (n=33) | 0 participants |
| Participants With Less Ecchymosis Treated With SoC | Resolution of Edema as Assessed by Investigators. | By Day 3 (n=33) | 0 participants |
| Participants With Less Ecchymosis Treated With SoC | Resolution of Edema as Assessed by Investigators. | By Day 10 (n=32) | 0 participants |
| Participants With Equal Ecchymosis On Both Sides | Resolution of Edema as Assessed by Investigators. | By Day 3 (n=33) | 0 participants |
| Participants With Equal Ecchymosis On Both Sides | Resolution of Edema as Assessed by Investigators. | By Day 5 (n=33) | 0 participants |
| Participants With Equal Ecchymosis On Both Sides | Resolution of Edema as Assessed by Investigators. | By Day 7 (n=33) | 1 participants |
| Participants With Equal Ecchymosis On Both Sides | Resolution of Edema as Assessed by Investigators. | By Day 14 (n=32) | 6 participants |
| Participants With Equal Ecchymosis On Both Sides | Resolution of Edema as Assessed by Investigators. | By Day 10 (n=32) | 1 participants |
| Participants With Equal Ecchymosis On Both Sides | Resolution of Edema as Assessed by Investigators. | By Day 1 (n=32) | 0 participants |
| Participants With No Ecchymosis on Either Side | Resolution of Edema as Assessed by Investigators. | By Day 10 (n=32) | 30 participants |
| Participants With No Ecchymosis on Either Side | Resolution of Edema as Assessed by Investigators. | By Day 14 (n=32) | 20 participants |
| Participants With No Ecchymosis on Either Side | Resolution of Edema as Assessed by Investigators. | By Day 3 (n=33) | 33 participants |
| Participants With No Ecchymosis on Either Side | Resolution of Edema as Assessed by Investigators. | By Day 7 (n=33) | 33 participants |
| Participants With No Ecchymosis on Either Side | Resolution of Edema as Assessed by Investigators. | By Day 1 (n=32) | 29 participants |
| Participants With No Ecchymosis on Either Side | Resolution of Edema as Assessed by Investigators. | By Day 5 (n=33) | 33 participants |
Secondary
Total Volume of Drainage on Each Side of the Face
Time frame: 24 hours postoperative
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Total Volume of Drainage on Each Side of the Face | 16 mL |
| Participants With Less Ecchymosis Treated With SoC | Total Volume of Drainage on Each Side of the Face | 5 mL |
p-value: 0.001two-sided paired t-test
Secondary
Visual Comparison of Ecchymosis at Day 1
Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.
Time frame: Through Postoperative Day 1
Population: Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Visual Comparison of Ecchymosis at Day 1 | 2 participants |
| Participants With Less Ecchymosis Treated With SoC | Visual Comparison of Ecchymosis at Day 1 | 11 participants |
| Participants With Equal Ecchymosis On Both Sides | Visual Comparison of Ecchymosis at Day 1 | 16 participants |
| Participants With No Ecchymosis on Either Side | Visual Comparison of Ecchymosis at Day 1 | 0 participants |
90% CI: [0.12, 0.48]
Secondary
Visual Comparison of Ecchymosis at Day 10
Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.
Time frame: Through Postoperative Day 10
Population: Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Visual Comparison of Ecchymosis at Day 10 | 7 participants |
| Participants With Less Ecchymosis Treated With SoC | Visual Comparison of Ecchymosis at Day 10 | 7 participants |
| Participants With Equal Ecchymosis On Both Sides | Visual Comparison of Ecchymosis at Day 10 | 14 participants |
| Participants With No Ecchymosis on Either Side | Visual Comparison of Ecchymosis at Day 10 | 0 participants |
90% CI: [-0.21, 0.21]
Secondary
Visual Comparison of Ecchymosis at Day 14
Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.
Time frame: Through Postoperative Day 14
Population: Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Visual Comparison of Ecchymosis at Day 14 | 5 participants |
| Participants With Less Ecchymosis Treated With SoC | Visual Comparison of Ecchymosis at Day 14 | 6 participants |
| Participants With Equal Ecchymosis On Both Sides | Visual Comparison of Ecchymosis at Day 14 | 14 participants |
| Participants With No Ecchymosis on Either Side | Visual Comparison of Ecchymosis at Day 14 | 1 participants |
90% CI: [-0.17, 0.24]
Secondary
Visual Comparison of Ecchymosis at Day 5
Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.
Time frame: Through Postoperative Day 5
Population: Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Visual Comparison of Ecchymosis at Day 5 | 5 participants |
| Participants With Less Ecchymosis Treated With SoC | Visual Comparison of Ecchymosis at Day 5 | 8 participants |
| Participants With Equal Ecchymosis On Both Sides | Visual Comparison of Ecchymosis at Day 5 | 14 participants |
| Participants With No Ecchymosis on Either Side | Visual Comparison of Ecchymosis at Day 5 | 0 participants |
90% CI: [-0.11, 0.32]
Secondary
Visual Comparison of Ecchymosis at Day 7
Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.
Time frame: Through Postoperative Day 7
Population: Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | Visual Comparison of Ecchymosis at Day 7 | 9 participants |
| Participants With Less Ecchymosis Treated With SoC | Visual Comparison of Ecchymosis at Day 7 | 8 participants |
| Participants With Equal Ecchymosis On Both Sides | Visual Comparison of Ecchymosis at Day 7 | 14 participants |
| Participants With No Ecchymosis on Either Side | Visual Comparison of Ecchymosis at Day 7 | 0 participants |
90% CI: [-0.24, 0.18]