Face-lift, Facial Rhytidectomy
Conditions
Brief summary
The purpose of the study is to compare the safety and efficacy of FS VH S/D 4 s-apr versus standard of care in adhering tissue and improving wound healing in subjects undergoing facelift.
Interventions
BIOLOGICALFS VH S/D 4 s-apr
FS VH S/D 4 s-apr will be applied (using spray device provided by Sponsor) to the subcutaneous plane (intraoperative, topical administration) in both the neck and the face area.
Sponsors
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subject is 18 to 75 years of age at the time of screening * Subject is planned for facial rhytidectomy * Subject has read, understood and signed the written informed consent * Subject is healthy, as determined by the investigator using standard pre-operative assessments to include laboratory tests and electrocardiograms * Subject is of childbearing potential, presents with a negative serum pregnancy test, and agrees to employ adequate birth control measures for the duration of the study * Subject is willing and able to comply with the requirements of the protocol
Exclusion criteria
* Subject is indicated for an abbreviated or modified face-lift procedure such as deep plane procedures, minimal undermining procedures, thread lifts, and minimal access cranial suspension * Subject is indicated for concurrent facial surgeries during the operation (eg forehead plasty,blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.) * Subject is indicated for additional procedures to the body during the same operation (eg liposuction, mastoplasty etc.) * Subject has undergone a prior rhytidectomy surgery * Subject is an active smoker, as assessed by the investigator * Subject has a known (documented) bleeding or coagulation disorder * Subject is being treated with anti-coagulants or with Aspirin (that was not discontinued 7 days prior to surgery) * Subject has a vascular disorder, cardiovascular disease, and/or uncontrolled hypertension * Subject has diabetes mellitus with glycosylated hemoglobin (HbA1c) \> 7 * Subject is receiving active treatment for a malignancy * Subject has a connective tissue disorder * Subject has an active or chronic skin disorder * Subject has history of Bell's palsy * Subject has a documented history of pathologically or pharmacologically induced immune deficiency * Subject has received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery * Subject has a known sensitivity to components of FS VH S/D 4 s-apr * Subject has a known psychiatric disorder (eg, obsessive compulsive disorder, anxiety, eating disorders, etc.) * Subject has documented healing complications following previous surgeries (eg, hypertrophic scarring) * Subject is pregnant or lactating at the time of enrollment * Subject has participated in another clinical study involving an investigational product/device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product/device during the course of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Volume of Drainage on Each Side of the Face | 24 hours (± 4h) after surgery | Total drainage volume collected from each side of the face. One side of face is treated with FS VH S/D 4 s-apr (FS); the other side is treated using standard of care (SoC). |
| Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) | Day 0 (day of surgery) through postoperative Day 14 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3 | Through postoperative Day 3 | Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema |
| Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14 | Day 0 (preoperative) through postoperative Day 14 | Skin sensitivity was measured using Semmes-Weinstein Monofilament set to detect neurological damage. Filament sizes are noted by handle numbers of measuring tools (\[handle number = log10(10\*force in milligrams applied to skin)\], range = 1.65 to 6.65). Detection of filament with smaller handle number = greater skin sensitivity. Smaller change in filament size detection from pre-op to post-op = less impact to recovery of sensation. Smallest filament felt for each side of face was noted. Change in skin sensitivity computed as (Handle Number Postop Day 3, 7, or 14) - (Handle Number Preop Day 0). |
| Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 | Through postoperative Day 14 | Participants responded to the following question during the side of face preference assessment: Which side of the face do you prefer? Left side, right side, or no preference? |
| Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1 | Through postoperative Day 1 | Participants responded to the following question during the side of face preference assessment: Which side of the face do you prefer? Left side, right side, or no preference? |
| Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3 | Through postoperative Day 3 | Participants responded to the following question during the side of face preference assessment: Which side of the face do you prefer? Left side, right side, or no preference? |
| Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7 | Through postoperative Day 7 | Participants responded to the following question during the side of face preference assessment: Which side of the face do you prefer? Left side, right side, or no preference? |
| Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14 | Through postoperative Day 14 | Participants responded to the following question during the side of face preference assessment: Which side of the face do you prefer? Left side, right side, or no preference? |
| Reasons for Participants' Preferences for Side of Face | Through postoperative Day 14 | Participants responded to the following questions during the side of face preference assessment: 1. Which side of the face do you prefer? Left side, right side, or no preference? 2. If right or left is chosen, participants were asked Please mark ALL reasons for choosing this side 1. Better skin sensation 2. Less numbness 3. Looks better 4. Less bruising 5. Less swelling 6. Less pain 7. Less itching 8. Less tingling 9. Less feeling of pins and needles 10. Other \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ (Free Text) |
| Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 0 (day of surgery) through postoperative day 14 | Investigators assessed each side of the face for the presence of hematomas and/or seromas |
| Participants With Hematoma/Seroma by Study Day | Day 0 (day of surgery) through postoperative day 14 | Investigators assessed each side of the face for the presence of hematoma and/or seroma |
| Number of Participants With Hematoma/Seroma Anytime During the Study | Day 0 (day of surgery) through postoperative Day 14 | — |
| Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 1 | Through postoperative Day 1 | Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema |
| Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7 | Through postoperative Day 7 | Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema |
| Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14 | Through postoperative Day 14 | Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema |
Other
| Measure | Time frame | Description |
|---|---|---|
| Investigators' Satisfaction With Rate of Healing | Through postoperative Day 14 | During postoperative visits investigators recorded their satisfaction with the rate of healing of each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face) |
| Investigators' Satisfaction With Treatment | Through postoperative Day 14 | During postoperative visits investigators recorded their satisfaction with treatment on each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face) |
| Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Through postoperative Day 14 | — |
| Total Aspiration Volumes From Hematomas and Seromas | Through postoperative Day 14 | — |
| Investigators' Satisfaction With Quality of Flap Adherence | Through postoperative Day 14 | During postoperative visits investigators recorded their satisfaction with the quality of flap adherence for each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face) |
| Participants' Assessment of Difference in Numbness Between Two Sides of Face | Through postoperative Day 14 | During each postoperative visit (Day 1, 3, 7, and 14), participants were asked: How would you rate your numbness on each side of your face on a scale of 0-10, with 10 being the worst numbness possible? Difference in scores on a scale = (SoC score) - (FS VH S/D 4 s-apr score) The planned and approved Statistical Analysis Plan (SAP) called for 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. |
| Investigator Preference for Side of Face | Through postoperative Day 14 | Investigator reported outcomes data was collected for overall preference for 1 side of face |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled at 7 clinical sites in the United States, beginning September 2009 and completing in December 2009
Pre-assignment details
79 participants were enrolled and screened. 2 were screen failures and 2 requested withdrawal. Therefore, 75 of the 79 enrolled were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Facelift Participants One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care (SoC), and the other side of the face will receive SoC alone. Please note: Each subject will participate in both arms (investigational product and SoC) simultaneously, and will serve as his/her own control. | 75 |
| Total | 75 |
Baseline characteristics
| Characteristic | Facelift Participants |
|---|---|
| Age Continuous | 54.4 years STANDARD_DEVIATION 7.4 |
| Region of Enrollment United States | 75 participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 4 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 | 8 / 75 | 5 / 75 | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 | 1 / 75 | 1 / 75 |
Outcome results
Primary
Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr)
Time frame: Day 0 (day of surgery) through postoperative Day 14
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) | Serious Adverse Events- Mild | 0 Events |
| Standard of Care (SoC) | Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) | Serious Adverse Events- Moderate | 0 Events |
| Standard of Care (SoC) | Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) | Serious Adverse Events- Severe | 0 Events |
| Standard of Care (SoC) | Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) | non-Serious Adverse Events- Mild | 0 Events |
| Standard of Care (SoC) | Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) | non-Serious Adverse Events- Moderate | 0 Events |
| Standard of Care (SoC) | Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) | non-Serious Adverse Events- Severe | 0 Events |
| FS VH S/D 4 S-apr | Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) | non-Serious Adverse Events- Moderate | 0 Events |
| FS VH S/D 4 S-apr | Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) | Serious Adverse Events- Mild | 0 Events |
| FS VH S/D 4 S-apr | Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) | non-Serious Adverse Events- Mild | 2 Events |
| FS VH S/D 4 S-apr | Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) | Serious Adverse Events- Moderate | 1 Events |
| FS VH S/D 4 S-apr | Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) | non-Serious Adverse Events- Severe | 0 Events |
| FS VH S/D 4 S-apr | Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) | Serious Adverse Events- Severe | 0 Events |
Primary
Total Volume of Drainage on Each Side of the Face
Total drainage volume collected from each side of the face. One side of face is treated with FS VH S/D 4 s-apr (FS); the other side is treated using standard of care (SoC).
Time frame: 24 hours (± 4h) after surgery
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care (SoC) | Total Volume of Drainage on Each Side of the Face | 20.0 mL |
| FS VH S/D 4 S-apr | Total Volume of Drainage on Each Side of the Face | 8.0 mL |
p-value: <0.0001two-sided paired t-test
Secondary
Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14
Skin sensitivity was measured using Semmes-Weinstein Monofilament set to detect neurological damage. Filament sizes are noted by handle numbers of measuring tools (\[handle number = log10(10\*force in milligrams applied to skin)\], range = 1.65 to 6.65). Detection of filament with smaller handle number = greater skin sensitivity. Smaller change in filament size detection from pre-op to post-op = less impact to recovery of sensation. Smallest filament felt for each side of face was noted. Change in skin sensitivity computed as (Handle Number Postop Day 3, 7, or 14) - (Handle Number Preop Day 0).
Time frame: Day 0 (preoperative) through postoperative Day 14
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care (SoC) | Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14 | Day 3 | 0.54 Handle number(s) | 95% Confidence Interval 0.85 |
| Standard of Care (SoC) | Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14 | Day 7 | 0.44 Handle number(s) | 95% Confidence Interval 0.94 |
| Standard of Care (SoC) | Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14 | Day 14 | 0.24 Handle number(s) | 95% Confidence Interval 0.82 |
| FS VH S/D 4 S-apr | Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14 | Day 3 | 0.60 Handle number(s) | 95% Confidence Interval 0.94 |
| FS VH S/D 4 S-apr | Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14 | Day 7 | 0.51 Handle number(s) | 95% Confidence Interval 1.02 |
| FS VH S/D 4 S-apr | Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14 | Day 14 | 0.32 Handle number(s) | 95% Confidence Interval 0.96 |
Secondary
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 1
Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema
Time frame: Through postoperative Day 1
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (SoC) | Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 1 | 40 participants |
| FS VH S/D 4 S-apr | Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 1 | 12 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 1 | 23 participants |
p-value: <0.00195% CI: [-0.524, -0.193]McNemar
Secondary
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14
Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema
Time frame: Through postoperative Day 14
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (SoC) | Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14 | 27 participants |
| FS VH S/D 4 S-apr | Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14 | 13 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14 | 34 participants |
p-value: 0.02795% CI: [-0.342, -0.023]McNemar
Secondary
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3
Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema
Time frame: Through postoperative Day 3
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (SoC) | Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3 | 41 participants |
| FS VH S/D 4 S-apr | Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3 | 12 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3 | 22 participants |
p-value: <0.00195% CI: [-0.538, -0.205]McNemar
Secondary
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7
Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema
Time frame: Through postoperative Day 7
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (SoC) | Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7 | 41 participants |
| FS VH S/D 4 S-apr | Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7 | 15 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7 | 17 participants |
p-value: 0.00195% CI: [-0.521, -0.161]McNemar
Secondary
Number of Participants With Hematoma/Seroma Anytime During the Study
Time frame: Day 0 (day of surgery) through postoperative Day 14
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (SoC) | Number of Participants With Hematoma/Seroma Anytime During the Study | 2 participants |
| FS VH S/D 4 S-apr | Number of Participants With Hematoma/Seroma Anytime During the Study | 5 participants |
| Standard of Care (SoC) Side - Hematoma | Number of Participants With Hematoma/Seroma Anytime During the Study | 3 participants |
| Standard of Care (SoC) Side - Seroma | Number of Participants With Hematoma/Seroma Anytime During the Study | 65 participants |
p-value: 0.25795% CI: [-0.039, 0.125]McNemar
Secondary
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14
Participants responded to the following question during the side of face preference assessment: Which side of the face do you prefer? Left side, right side, or no preference?
Time frame: Through postoperative Day 14
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 | Day 1 (n= 75) | 47 participants |
| Standard of Care (SoC) | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 | Day 3 (n= 75) | 40 participants |
| Standard of Care (SoC) | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 | Day 7 (n= 75) | 44 participants |
| Standard of Care (SoC) | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 | Day 14 (n= 74) | 42 participants |
| FS VH S/D 4 S-apr | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 | Day 14 (n= 74) | 15 participants |
| FS VH S/D 4 S-apr | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 | Day 1 (n= 75) | 16 participants |
| FS VH S/D 4 S-apr | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 | Day 7 (n= 75) | 18 participants |
| FS VH S/D 4 S-apr | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 | Day 3 (n= 75) | 23 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 | Day 14 (n= 74) | 17 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 | Day 3 (n= 75) | 12 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 | Day 7 (n= 75) | 13 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 | Day 1 (n= 75) | 12 participants |
Secondary
Participants' First Occurrence of Hematoma or Seroma by Study Day
Investigators assessed each side of the face for the presence of hematomas and/or seromas
Time frame: Day 0 (day of surgery) through postoperative day 14
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 0 | 0 participants |
| Standard of Care (SoC) | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 11 | 0 participants |
| Standard of Care (SoC) | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 8 | 0 participants |
| Standard of Care (SoC) | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 2 | 0 participants |
| Standard of Care (SoC) | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 9 | 0 participants |
| Standard of Care (SoC) | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 10 | 0 participants |
| Standard of Care (SoC) | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 3 | 0 participants |
| Standard of Care (SoC) | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 1 | 1 participants |
| Standard of Care (SoC) | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 13 | 0 participants |
| Standard of Care (SoC) | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 4 | 0 participants |
| Standard of Care (SoC) | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 5 | 0 participants |
| Standard of Care (SoC) | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 12 | 0 participants |
| Standard of Care (SoC) | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 6 | 0 participants |
| Standard of Care (SoC) | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 14 | 0 participants |
| Standard of Care (SoC) | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 7 | 0 participants |
| FS VH S/D 4 S-apr | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 7 | 1 participants |
| FS VH S/D 4 S-apr | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 11 | 0 participants |
| FS VH S/D 4 S-apr | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 4 | 0 participants |
| FS VH S/D 4 S-apr | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 8 | 0 participants |
| FS VH S/D 4 S-apr | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 1 | 2 participants |
| FS VH S/D 4 S-apr | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 10 | 1 participants |
| FS VH S/D 4 S-apr | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 12 | 0 participants |
| FS VH S/D 4 S-apr | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 9 | 0 participants |
| FS VH S/D 4 S-apr | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 2 | 0 participants |
| FS VH S/D 4 S-apr | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 6 | 0 participants |
| FS VH S/D 4 S-apr | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 14 | 1 participants |
| FS VH S/D 4 S-apr | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 13 | 0 participants |
| FS VH S/D 4 S-apr | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 5 | 0 participants |
| FS VH S/D 4 S-apr | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 3 | 1 participants |
| FS VH S/D 4 S-apr | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 0 | 0 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 7 | 1 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 0 | 1 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 1 | 0 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 2 | 0 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 3 | 2 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 4 | 0 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 5 | 0 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 6 | 0 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 8 | 0 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 9 | 0 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 10 | 0 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 11 | 0 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 12 | 0 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 13 | 0 participants |
| Standard of Care (SoC) Side - Hematoma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 14 | 0 participants |
| Standard of Care (SoC) Side - Seroma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 6 | 0 participants |
| Standard of Care (SoC) Side - Seroma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 1 | 1 participants |
| Standard of Care (SoC) Side - Seroma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 11 | 0 participants |
| Standard of Care (SoC) Side - Seroma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 5 | 0 participants |
| Standard of Care (SoC) Side - Seroma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 4 | 0 participants |
| Standard of Care (SoC) Side - Seroma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 0 | 0 participants |
| Standard of Care (SoC) Side - Seroma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 12 | 0 participants |
| Standard of Care (SoC) Side - Seroma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 3 | 2 participants |
| Standard of Care (SoC) Side - Seroma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 2 | 0 participants |
| Standard of Care (SoC) Side - Seroma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 14 | 0 participants |
| Standard of Care (SoC) Side - Seroma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 9 | 0 participants |
| Standard of Care (SoC) Side - Seroma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 8 | 0 participants |
| Standard of Care (SoC) Side - Seroma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 13 | 0 participants |
| Standard of Care (SoC) Side - Seroma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 10 | 0 participants |
| Standard of Care (SoC) Side - Seroma | Participants' First Occurrence of Hematoma or Seroma by Study Day | Day 7 | 1 participants |
Secondary
Participants With Hematoma/Seroma by Study Day
Investigators assessed each side of the face for the presence of hematoma and/or seroma
Time frame: Day 0 (day of surgery) through postoperative day 14
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Participants With Hematoma/Seroma by Study Day | Day 4 | 1 participants |
| Standard of Care (SoC) | Participants With Hematoma/Seroma by Study Day | Day 8 | 1 participants |
| Standard of Care (SoC) | Participants With Hematoma/Seroma by Study Day | Day 1 | 3 participants |
| Standard of Care (SoC) | Participants With Hematoma/Seroma by Study Day | Day 9 | 1 participants |
| Standard of Care (SoC) | Participants With Hematoma/Seroma by Study Day | Day 5 | 0 participants |
| Standard of Care (SoC) | Participants With Hematoma/Seroma by Study Day | Day 10 | 2 participants |
| Standard of Care (SoC) | Participants With Hematoma/Seroma by Study Day | Day 3 | 2 participants |
| Standard of Care (SoC) | Participants With Hematoma/Seroma by Study Day | Day 11 | 0 participants |
| Standard of Care (SoC) | Participants With Hematoma/Seroma by Study Day | Day 6 | 0 participants |
| Standard of Care (SoC) | Participants With Hematoma/Seroma by Study Day | Day 12 | 0 participants |
| Standard of Care (SoC) | Participants With Hematoma/Seroma by Study Day | Day 2 | 2 participants |
| Standard of Care (SoC) | Participants With Hematoma/Seroma by Study Day | Day 13 | 0 participants |
| Standard of Care (SoC) | Participants With Hematoma/Seroma by Study Day | Day 7 | 1 participants |
| Standard of Care (SoC) | Participants With Hematoma/Seroma by Study Day | Day 14 | 1 participants |
| Standard of Care (SoC) | Participants With Hematoma/Seroma by Study Day | Day 0 | 0 participants |
| FS VH S/D 4 S-apr | Participants With Hematoma/Seroma by Study Day | Day 14 | 1 participants |
| FS VH S/D 4 S-apr | Participants With Hematoma/Seroma by Study Day | Day 0 | 1 participants |
| FS VH S/D 4 S-apr | Participants With Hematoma/Seroma by Study Day | Day 1 | 1 participants |
| FS VH S/D 4 S-apr | Participants With Hematoma/Seroma by Study Day | Day 2 | 1 participants |
| FS VH S/D 4 S-apr | Participants With Hematoma/Seroma by Study Day | Day 3 | 4 participants |
| FS VH S/D 4 S-apr | Participants With Hematoma/Seroma by Study Day | Day 4 | 4 participants |
| FS VH S/D 4 S-apr | Participants With Hematoma/Seroma by Study Day | Day 5 | 3 participants |
| FS VH S/D 4 S-apr | Participants With Hematoma/Seroma by Study Day | Day 6 | 0 participants |
| FS VH S/D 4 S-apr | Participants With Hematoma/Seroma by Study Day | Day 7 | 2 participants |
| FS VH S/D 4 S-apr | Participants With Hematoma/Seroma by Study Day | Day 8 | 2 participants |
| FS VH S/D 4 S-apr | Participants With Hematoma/Seroma by Study Day | Day 9 | 2 participants |
| FS VH S/D 4 S-apr | Participants With Hematoma/Seroma by Study Day | Day 10 | 2 participants |
| FS VH S/D 4 S-apr | Participants With Hematoma/Seroma by Study Day | Day 11 | 1 participants |
| FS VH S/D 4 S-apr | Participants With Hematoma/Seroma by Study Day | Day 12 | 1 participants |
| FS VH S/D 4 S-apr | Participants With Hematoma/Seroma by Study Day | Day 13 | 1 participants |
Secondary
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1
Participants responded to the following question during the side of face preference assessment: Which side of the face do you prefer? Left side, right side, or no preference?
Time frame: Through postoperative Day 1
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (SoC) | Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1 | 0.63 Proportion of Participants |
| FS VH S/D 4 S-apr | Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1 | 0.21 Proportion of Participants |
95% CI: [-0.577, -0.213]
Secondary
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14
Participants responded to the following question during the side of face preference assessment: Which side of the face do you prefer? Left side, right side, or no preference?
Time frame: Through postoperative Day 14
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (SoC) | Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14 | 0.57 Proportion of Participants |
| FS VH S/D 4 S-apr | Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14 | 0.20 Proportion of Participants |
95% CI: [-0.528, -0.171]
Secondary
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3
Participants responded to the following question during the side of face preference assessment: Which side of the face do you prefer? Left side, right side, or no preference?
Time frame: Through postoperative Day 3
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (SoC) | Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3 | 0.53 Proportion of Participants |
| FS VH S/D 4 S-apr | Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3 | 0.31 Proportion of Participants |
95% CI: [-0.413, -0.02]
Secondary
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7
Participants responded to the following question during the side of face preference assessment: Which side of the face do you prefer? Left side, right side, or no preference?
Time frame: Through postoperative Day 7
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (SoC) | Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7 | 0.59 Proportion of Participants |
| FS VH S/D 4 S-apr | Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7 | 0.24 Proportion of Participants |
95% CI: [-0.518, -0.145]
Secondary
Reasons for Participants' Preferences for Side of Face
Participants responded to the following questions during the side of face preference assessment: 1. Which side of the face do you prefer? Left side, right side, or no preference? 2. If right or left is chosen, participants were asked Please mark ALL reasons for choosing this side 1. Better skin sensation 2. Less numbness 3. Looks better 4. Less bruising 5. Less swelling 6. Less pain 7. Less itching 8. Less tingling 9. Less feeling of pins and needles 10. Other \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ (Free Text)
Time frame: Through postoperative Day 14
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Reasons for Participants' Preferences for Side of Face | Less Numbness | 16 Participants |
| Standard of Care (SoC) | Reasons for Participants' Preferences for Side of Face | Less Itching | 2 Participants |
| Standard of Care (SoC) | Reasons for Participants' Preferences for Side of Face | Other | 3 Participants |
| Standard of Care (SoC) | Reasons for Participants' Preferences for Side of Face | Looks Better | 35 Participants |
| Standard of Care (SoC) | Reasons for Participants' Preferences for Side of Face | Less Bruising | 21 Participants |
| Standard of Care (SoC) | Reasons for Participants' Preferences for Side of Face | Better Skin Sensation | 19 Participants |
| Standard of Care (SoC) | Reasons for Participants' Preferences for Side of Face | Less Tingling | 2 Participants |
| Standard of Care (SoC) | Reasons for Participants' Preferences for Side of Face | Less Swelling | 37 Participants |
| Standard of Care (SoC) | Reasons for Participants' Preferences for Side of Face | Less Pain | 23 Participants |
| Standard of Care (SoC) | Reasons for Participants' Preferences for Side of Face | Less Feeling of Pins and Needles | 4 Participants |
| FS VH S/D 4 S-apr | Reasons for Participants' Preferences for Side of Face | Better Skin Sensation | 5 Participants |
| FS VH S/D 4 S-apr | Reasons for Participants' Preferences for Side of Face | Less Itching | 2 Participants |
| FS VH S/D 4 S-apr | Reasons for Participants' Preferences for Side of Face | Less Numbness | 6 Participants |
| FS VH S/D 4 S-apr | Reasons for Participants' Preferences for Side of Face | Other | 0 Participants |
| FS VH S/D 4 S-apr | Reasons for Participants' Preferences for Side of Face | Less Swelling | 14 Participants |
| FS VH S/D 4 S-apr | Reasons for Participants' Preferences for Side of Face | Looks Better | 13 Participants |
| FS VH S/D 4 S-apr | Reasons for Participants' Preferences for Side of Face | Less Feeling of Pins and Needles | 1 Participants |
| FS VH S/D 4 S-apr | Reasons for Participants' Preferences for Side of Face | Less Tingling | 1 Participants |
| FS VH S/D 4 S-apr | Reasons for Participants' Preferences for Side of Face | Less Pain | 7 Participants |
| FS VH S/D 4 S-apr | Reasons for Participants' Preferences for Side of Face | Less Bruising | 8 Participants |
| Standard of Care (SoC) Side - Hematoma | Reasons for Participants' Preferences for Side of Face | Less Bruising | 21 Participants |
| Standard of Care (SoC) Side - Hematoma | Reasons for Participants' Preferences for Side of Face | Better Skin Sensation | 15 Participants |
| Standard of Care (SoC) Side - Hematoma | Reasons for Participants' Preferences for Side of Face | Less Feeling of Pins and Needles | 7 Participants |
| Standard of Care (SoC) Side - Hematoma | Reasons for Participants' Preferences for Side of Face | Less Itching | 7 Participants |
| Standard of Care (SoC) Side - Hematoma | Reasons for Participants' Preferences for Side of Face | Less Numbness | 24 Participants |
| Standard of Care (SoC) Side - Hematoma | Reasons for Participants' Preferences for Side of Face | Less Pain | 22 Participants |
| Standard of Care (SoC) Side - Hematoma | Reasons for Participants' Preferences for Side of Face | Less Swelling | 30 Participants |
| Standard of Care (SoC) Side - Hematoma | Reasons for Participants' Preferences for Side of Face | Less Tingling | 6 Participants |
| Standard of Care (SoC) Side - Hematoma | Reasons for Participants' Preferences for Side of Face | Looks Better | 32 Participants |
| Standard of Care (SoC) Side - Hematoma | Reasons for Participants' Preferences for Side of Face | Other | 3 Participants |
| Standard of Care (SoC) Side - Seroma | Reasons for Participants' Preferences for Side of Face | Less Numbness | 9 Participants |
| Standard of Care (SoC) Side - Seroma | Reasons for Participants' Preferences for Side of Face | Looks Better | 19 Participants |
| Standard of Care (SoC) Side - Seroma | Reasons for Participants' Preferences for Side of Face | Other | 1 Participants |
| Standard of Care (SoC) Side - Seroma | Reasons for Participants' Preferences for Side of Face | Less Pain | 8 Participants |
| Standard of Care (SoC) Side - Seroma | Reasons for Participants' Preferences for Side of Face | Less Swelling | 16 Participants |
| Standard of Care (SoC) Side - Seroma | Reasons for Participants' Preferences for Side of Face | Less Itching | 3 Participants |
| Standard of Care (SoC) Side - Seroma | Reasons for Participants' Preferences for Side of Face | Better Skin Sensation | 4 Participants |
| Standard of Care (SoC) Side - Seroma | Reasons for Participants' Preferences for Side of Face | Less Tingling | 3 Participants |
| Standard of Care (SoC) Side - Seroma | Reasons for Participants' Preferences for Side of Face | Less Feeling of Pins and Needles | 1 Participants |
| Standard of Care (SoC) Side - Seroma | Reasons for Participants' Preferences for Side of Face | Less Bruising | 14 Participants |
| FS VH S/D 4 S-apr Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Less Bruising | 30 Participants |
| FS VH S/D 4 S-apr Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Less Swelling | 33 Participants |
| FS VH S/D 4 S-apr Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Less Numbness | 24 Participants |
| FS VH S/D 4 S-apr Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Less Itching | 9 Participants |
| FS VH S/D 4 S-apr Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Better Skin Sensation | 19 Participants |
| FS VH S/D 4 S-apr Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Looks Better | 37 Participants |
| FS VH S/D 4 S-apr Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Less Pain | 26 Participants |
| FS VH S/D 4 S-apr Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Less Feeling of Pins and Needles | 8 Participants |
| FS VH S/D 4 S-apr Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Less Tingling | 9 Participants |
| FS VH S/D 4 S-apr Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Other | 3 Participants |
| SoC Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Less Itching | 1 Participants |
| SoC Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Less Numbness | 7 Participants |
| SoC Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Less Pain | 5 Participants |
| SoC Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Less Bruising | 9 Participants |
| SoC Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Less Swelling | 14 Participants |
| SoC Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Other | 0 Participants |
| SoC Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Less Tingling | 2 Participants |
| SoC Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Better Skin Sensation | 7 Participants |
| SoC Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Looks Better | 13 Participants |
| SoC Side - Day 7 | Reasons for Participants' Preferences for Side of Face | Less Feeling of Pins and Needles | 1 Participants |
| FS VH S/D 4 S-apr Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Less Pain | 25 Participants |
| FS VH S/D 4 S-apr Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Less Numbness | 28 Participants |
| FS VH S/D 4 S-apr Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Less Tingling | 16 Participants |
| FS VH S/D 4 S-apr Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Better Skin Sensation | 26 Participants |
| FS VH S/D 4 S-apr Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Other | 2 Participants |
| FS VH S/D 4 S-apr Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Less Bruising | 29 Participants |
| FS VH S/D 4 S-apr Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Looks Better | 35 Participants |
| FS VH S/D 4 S-apr Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Less Feeling of Pins and Needles | 11 Participants |
| FS VH S/D 4 S-apr Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Less Swelling | 36 Participants |
| FS VH S/D 4 S-apr Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Less Itching | 11 Participants |
| SoC Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Less Pain | 4 Participants |
| SoC Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Looks Better | 12 Participants |
| SoC Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Less Numbness | 11 Participants |
| SoC Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Less Tingling | 1 Participants |
| SoC Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Less Feeling of Pins and Needles | 1 Participants |
| SoC Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Other | 1 Participants |
| SoC Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Better Skin Sensation | 6 Participants |
| SoC Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Less Swelling | 12 Participants |
| SoC Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Less Bruising | 5 Participants |
| SoC Side - Day 14 | Reasons for Participants' Preferences for Side of Face | Less Itching | 0 Participants |
Other Pre-specified
Investigator Preference for Side of Face
Investigator reported outcomes data was collected for overall preference for 1 side of face
Time frame: Through postoperative Day 14
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Investigator Preference for Side of Face | Postoperative Day 7 | 16 participants |
| Standard of Care (SoC) | Investigator Preference for Side of Face | Postoperative Day 3 | 7 participants |
| Standard of Care (SoC) | Investigator Preference for Side of Face | Postoperative Day 14 | 16 participants |
| Standard of Care (SoC) | Investigator Preference for Side of Face | Postoperative Day 1 | 8 participants |
| FS VH S/D 4 S-apr | Investigator Preference for Side of Face | Postoperative Day 7 | 31 participants |
| FS VH S/D 4 S-apr | Investigator Preference for Side of Face | Postoperative Day 1 | 33 participants |
| FS VH S/D 4 S-apr | Investigator Preference for Side of Face | Postoperative Day 3 | 37 participants |
| FS VH S/D 4 S-apr | Investigator Preference for Side of Face | Postoperative Day 14 | 21 participants |
| Standard of Care (SoC) Side - Hematoma | Investigator Preference for Side of Face | Postoperative Day 1 | 21 participants |
| Standard of Care (SoC) Side - Hematoma | Investigator Preference for Side of Face | Postoperative Day 7 | 16 participants |
| Standard of Care (SoC) Side - Hematoma | Investigator Preference for Side of Face | Postoperative Day 3 | 18 participants |
| Standard of Care (SoC) Side - Hematoma | Investigator Preference for Side of Face | Postoperative Day 14 | 25 participants |
| Standard of Care (SoC) Side - Seroma | Investigator Preference for Side of Face | Postoperative Day 3 | 10 participants |
| Standard of Care (SoC) Side - Seroma | Investigator Preference for Side of Face | Postoperative Day 1 | 13 participants |
| Standard of Care (SoC) Side - Seroma | Investigator Preference for Side of Face | Postoperative Day 7 | 11 participants |
| Standard of Care (SoC) Side - Seroma | Investigator Preference for Side of Face | Postoperative Day 14 | 12 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigator Preference for Side of Face | Postoperative Day 3 | 3 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigator Preference for Side of Face | Postoperative Day 1 | 0 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigator Preference for Side of Face | Postoperative Day 14 | 1 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigator Preference for Side of Face | Postoperative Day 7 | 1 participants |
Other Pre-specified
Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr
Time frame: Through postoperative Day 14
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 1 | 0 participants |
| Standard of Care (SoC) | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 3 | 0 participants |
| Standard of Care (SoC) | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 7 | 0 participants |
| Standard of Care (SoC) | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 14 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 1 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 14 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 3 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 7 | 0 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 14 | 8 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 3 | 6 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 7 | 5 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 1 | 8 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 1 | 20 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 3 | 26 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 14 | 14 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 7 | 20 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 14 | 53 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 7 | 50 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 3 | 43 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Day 1 | 47 participants |
Other Pre-specified
Investigators' Satisfaction With Quality of Flap Adherence
During postoperative visits investigators recorded their satisfaction with the quality of flap adherence for each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)
Time frame: Through postoperative Day 14
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 1 | 1 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 3 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 7 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 14 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 1 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 3 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 7 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 14 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 7 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 3 | 1 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 1 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 14 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 3 | 1 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 14 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 1 | 7 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 7 | 0 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 7 | 11 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 14 | 5 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 14 | 1 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 3 | 23 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 7 | 1 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 3 | 6 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 1 | 8 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 1 | 13 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 3 | 18 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 7 | 14 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 14 | 12 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 1 | 26 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 3 | 13 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 14 | 21 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 1 | 19 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 7 | 25 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 14 | 62 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 14 | 49 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 7 | 60 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 7 | 39 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 1 | 47 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 3 | 38 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence FS Side- Day 3 | 50 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Quality of Flap Adherence | Satisfaction with flap adherence SoC Side- Day 1 | 29 participants |
Other Pre-specified
Investigators' Satisfaction With Rate of Healing
During postoperative visits investigators recorded their satisfaction with the rate of healing of each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)
Time frame: Through postoperative Day 14
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 1 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 7 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 1 | 1 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 14 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 7 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 3 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 14 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 3 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 7 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 14 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 3 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 7 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 1 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 14 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 1 | 6 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 3 | 1 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 1 | 10 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 14 | 6 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 7 | 11 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 1 | 14 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 3 | 7 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 3 | 17 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 7 | 1 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 14 | 2 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 7 | 14 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 14 | 20 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 1 | 28 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 14 | 11 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 7 | 24 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 1 | 21 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 3 | 19 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 3 | 17 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 14 | 49 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 1 | 36 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 3 | 49 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 7 | 60 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 1 | 34 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 3 | 40 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing SoC Side- Day 7 | 40 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Rate of Healing | Satisfaction with Rate of Healing FS Side- Day 14 | 62 participants |
Other Pre-specified
Investigators' Satisfaction With Treatment
During postoperative visits investigators recorded their satisfaction with treatment on each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)
Time frame: Through postoperative Day 14
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 14 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 1 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 7 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 1 | 1 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 3 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 7 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 3 | 0 participants |
| Standard of Care (SoC) | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 14 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 7 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 3 | 2 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 3 | 1 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 14 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 7 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 14 | 0 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 1 | 6 participants |
| FS VH S/D 4 S-apr | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 1 | 0 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 1 | 15 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 14 | 2 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 1 | 7 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 7 | 11 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 3 | 14 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 7 | 2 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 14 | 5 participants |
| Standard of Care (SoC) Side - Hematoma | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 3 | 5 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 1 | 19 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 3 | 13 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 7 | 12 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 14 | 10 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 1 | 17 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 3 | 16 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 7 | 19 participants |
| Standard of Care (SoC) Side - Seroma | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 14 | 19 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 14 | 63 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 14 | 51 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 7 | 45 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 7 | 61 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 3 | 56 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on FS Side- Day 1 | 48 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 3 | 43 participants |
| FS VH S/D 4 S-apr Side - Day 7 | Investigators' Satisfaction With Treatment | Satisfaction with Treatment on SoC Side- Day 1 | 37 participants |
Other Pre-specified
Participants' Assessment of Difference in Numbness Between Two Sides of Face
During each postoperative visit (Day 1, 3, 7, and 14), participants were asked: How would you rate your numbness on each side of your face on a scale of 0-10, with 10 being the worst numbness possible? Difference in scores on a scale = (SoC score) - (FS VH S/D 4 s-apr score) The planned and approved Statistical Analysis Plan (SAP) called for 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: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care (SoC) | Participants' Assessment of Difference in Numbness Between Two Sides of Face | Postoperative Day 1 | 0.3 Scores on a scale | Standard Deviation 2 |
| Standard of Care (SoC) | Participants' Assessment of Difference in Numbness Between Two Sides of Face | Postoperative Day 3 | 0.4 Scores on a scale | Standard Deviation 1.7 |
| Standard of Care (SoC) | Participants' Assessment of Difference in Numbness Between Two Sides of Face | Postoperative Day 7 | 0.3 Scores on a scale | Standard Deviation 1.4 |
| Standard of Care (SoC) | Participants' Assessment of Difference in Numbness Between Two Sides of Face | Postoperative Day 14 | 0.5 Scores on a scale | Standard Deviation 1.4 |
Other Pre-specified
Total Aspiration Volumes From Hematomas and Seromas
Time frame: Through postoperative Day 14
Population: Full Analysis Data Set = All randomized and treated participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care (SoC) | Total Aspiration Volumes From Hematomas and Seromas | NA mL |
| FS VH S/D 4 S-apr | Total Aspiration Volumes From Hematomas and Seromas | 4.1 mL |
| Standard of Care (SoC) Side - Hematoma | Total Aspiration Volumes From Hematomas and Seromas | 4.7 mL |
| Standard of Care (SoC) Side - Seroma | Total Aspiration Volumes From Hematomas and Seromas | 7.0 mL |