Hematoma, Seroma
Conditions
Keywords
Abdominoplasty, Flap adherence in subjects undergoing abdominoplasty to eliminate dead space and reduce seroma/hematoma formation
Brief summary
The purpose of the study is to compare the safety and efficacy of ARTISS versus standard of care in adhering tissue places and reducing seroma/hematoma formation in subjects undergoing abdominoplasty.
Interventions
BIOLOGICALFS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)
Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed.
PROCEDUREStandard of care
Standard of care
Sponsors
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is 18 to 75 years of age at the time of screening * Subject is planned for primary standard abdominoplasty (status post Cesarean section or liposuction performed more than 6 months prior to enrollment in the study are allowed) * If the subject is of childbearing potential; presents with a negative pregnancy test, and agrees to employ adequate birth control measures for the duration of the study * Subject resides within 100 miles of the investigational site and is willing and able to comply with the scheduling requirements of the protocol (notably home visits by study personnel) * Subject is willing and able to comply with the requirements of the protocol
Exclusion criteria
* Subject is obese (body mass index \[BMI\] \> 30 before surgery) * Subject has experienced massive weight loss (subject has a history of obesity during adult life; subject lost more than 20 BMI unit score, subject has undergone a bariatric surgery) * Subject has a history of active smoking within the previous 12 months * Subject is elected for a non-standard abdominoplasty (extended, limited or mini-abdominoplasty, endoscopic, fleur-de-lis or circumferential abdominoplasty) or panniculectomy * Subject has scars on the abdominal wall above the umbilicus. Vertical midline, laparoscopic punctures, or liposuction punctures are permitted * Subject is planned for other body lifting procedures (eg to the arms, legs, back etc.) * Subject is planned for combined abdominoplasty with other cosmetic procedures including liposuction (restricted liposuction of the waist line and the lower back is allowed, as long as the integrity of the surgical spaces is maintained) * Subject has an active or chronic skin disorder, history or evidence of keloid formation, or hypertrophic scarring * Subject has a history of gastrointestinal disorders (eg Irritable Bowel Syndrome) requiring prescription medications * Subject has a known abdominal hernia that requires mesh fixation * Subject has a documented hiatal hernia or acid reflux disease * Subjects with congenital or acquired immunodeficiency disorders * Subject has uncontrolled diabetes mellitus (HbA1c \> 7.0) * Subject has a history of cardio-vascular disease including uncontrolled hypertension (\> 140/90 mm Hg) * Subject has a clinically diagnosed psychiatric disorder (including obsessive compulsive disorders) * Subject has a known (documented) bleeding or coagulation disorder including history of thromboembolic events * Subject is being treated with anti-coagulants or with Aspirin (that was not discontinued 7 days prior to surgery) * Subject is receiving active treatment for a malignancy * Subject has a connective tissue disorder * Subject has received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery * Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study * Subject has a known sensitivity to fibrin sealants * Subject is a friend, employee, or relative of the investigator or other study personnel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Drainage Volume Collected Until Drain Removal | Day 0 (Surgery Day) to Day 90 | Drainage fluids were to be collected through the Blake drain and into the collection bulb. The drainage volume was measured and recorded daily until the removal of the drain. During scheduled visits, measurement was to be performed at the study site, and on non-visit day recording of the drainage volume was to be done by a visiting home care nurse (or other study personnel). The drain was ready to be removed when the drainage volume in a given 24 hour period was \<=30 cc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Hematoma | Day 0 (Surgery Day) to Day 90 | The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of hematoma. A hematoma is a collection of blood outside of a blood vessel. |
| Time to Drain Removal | Day 0 (Surgery Day) up to Day 90 | The drain was ready to be removed when the drainage volume in a given 24 hour period was \<=30cc. |
| Number of Fluid Aspiration for Seromas | Day 0 (Surgery Day) to Day 90 | Number of interventions recorded. |
| Total Volume of Fluid Aspirations for Seromas | Day 0 (Surgery Day) to Day 90 | Volume of fluid recovered was recorded. |
| Occurrence of Seroma | Day 0 (Surgery Day) to Day 90 | The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of seroma. A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery. This fluid is composed of blood plasma that has seeped out of ruptured small blood vessels and inflammatory fluid produced by the injured and dying cells. |
| Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus | Days 0 (Baseline), 3, 7, 14, 28, 60, 90 | Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments, pressing at a 90 degree angle for approximately 1.5 seconds against the skin until it bows then it is removed. The patient is instructed to respond when a stimuli is felt, and a score is applied based on the monofilament in use. A higher score indiactes a greater loss of sensation. |
| Summary of Pain Assessment by Visit | Day 3, 7, 14, 28, 60, 90 | Subjects were to be presented with a non-verbal visual analogue scale (VAS) to measure the level of pain (rating 0 \[no pain\] to 10 \[worst possible pain\]) the patient experienced at the site of surgery at the time of the visit. |
| Summary of Numbness Assessment by Visit | Day 3, 7, 14, 28, 60, 90 | Subjects were to be presented with a non-verbal VAS to measure the level of numbness (rating 0 \[no numbness\] to 10 \[complete numbness\]) that the patient experienced at the time of the visit. |
| Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus | Days 0 (Baseline), 3, 7, 14, 28, 60, 90 | Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments. A higher score indicates a greater loss of sensation. Evaluator Size=ES, Hand & Dorsal Foot Thresholds=HDFT, Normal=N, Diminished Light Touch=DLT,Diminished Protective Sensation=DPS, Loss of Protective Sensation=LOPS, Deep Pressure Sensation Only=DPSO: ES=1.65 (minimum),HDFT=N;ES=2.36,HDFT=N;ES=2.44,HDFT=N;ES=2.83,HDFT=N;ES=3.22,HDFT=DLT;ES=3.61,HDFT=DLT;ES=3.84,HDFT=DPS;ES=4.08,HDFT=DPS;ES-4.17,HDFT=DPS;ES=4.31,HDFT=DPS;ES=4.56,HDFT=LOPS;ES=4.74,HDFT=LOPS;ES=4.93,HDFT=LOPS;ES=5.07,HDFT=LOPS;ES=5.18,HDFT=LOPS;ES=5.46,HDFT=LOPS;ES=5.88,HDFT=LOPS;ES=6.10,HDFT=LOPS;ES=6.45,HDFT=LOPS;ES=6.65 (maximum),HDFT=DPSO. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ARTISS ARTISS will be used as an adjuvant to standard of care.
ARTISS, also known as FS VH S/D 4 s-apr is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma.
The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period. | 20 |
| Standard of Care Standard of care | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Standard of Care | Total | ARTISS |
|---|---|---|---|
| Age, Continuous | 45.60 Years STANDARD_DEVIATION 10.32 | 43.25 Years STANDARD_DEVIATION 9.38 | 40.90 Years STANDARD_DEVIATION 7.89 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 13 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 27 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 38 Participants | 18 Participants |
| Sex: Female, Male Female | 19 Participants | 39 Participants | 20 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 10 / 20 | 7 / 20 |
| serious Total, serious adverse events | 1 / 20 | 0 / 20 |
Outcome results
Primary
Total Drainage Volume Collected Until Drain Removal
Drainage fluids were to be collected through the Blake drain and into the collection bulb. The drainage volume was measured and recorded daily until the removal of the drain. During scheduled visits, measurement was to be performed at the study site, and on non-visit day recording of the drainage volume was to be done by a visiting home care nurse (or other study personnel). The drain was ready to be removed when the drainage volume in a given 24 hour period was \<=30 cc.
Time frame: Day 0 (Surgery Day) to Day 90
Population: Full Analysis Set (FAS) consists of all subjects who were randomized (ie, the investigator opened the randomization envelope) and treated and who had an available assessment for the primary efficacy endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ARTISS | Total Drainage Volume Collected Until Drain Removal | 407.45 mL | Standard Deviation 470.36 |
| Standard of Care | Total Drainage Volume Collected Until Drain Removal | 595.90 mL | Standard Deviation 519.46 |
Secondary
Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus
Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments, pressing at a 90 degree angle for approximately 1.5 seconds against the skin until it bows then it is removed. The patient is instructed to respond when a stimuli is felt, and a score is applied based on the monofilament in use. A higher score indiactes a greater loss of sensation.
Time frame: Days 0 (Baseline), 3, 7, 14, 28, 60, 90
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARTISS | Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus | Day 3 | 1.81 Score on a Scale | Standard Deviation 1.83 |
| ARTISS | Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus | Day 7 | 1.47 Score on a Scale | Standard Deviation 1.32 |
| ARTISS | Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus | Day 14 | 1.28 Score on a Scale | Standard Deviation 1.47 |
| ARTISS | Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus | Day 28 | 1.21 Score on a Scale | Standard Deviation 1.43 |
| ARTISS | Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus | Day 60 | 0.97 Score on a Scale | Standard Deviation 1.67 |
| ARTISS | Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus | Day 90 | 1.00 Score on a Scale | Standard Deviation 1.68 |
| Standard of Care | Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus | Day 60 | 0.50 Score on a Scale | Standard Deviation 1.55 |
| Standard of Care | Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus | Day 3 | 1.78 Score on a Scale | Standard Deviation 1.67 |
| Standard of Care | Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus | Day 28 | 0.81 Score on a Scale | Standard Deviation 1.45 |
| Standard of Care | Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus | Day 7 | 1.02 Score on a Scale | Standard Deviation 1.52 |
| Standard of Care | Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus | Day 90 | 0.84 Score on a Scale | Standard Deviation 1.42 |
| Standard of Care | Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus | Day 14 | 0.49 Score on a Scale | Standard Deviation 1.25 |
Comparison: Day 3p-value: 0.9699Wilcoxon (Mann-Whitney)
Comparison: Day 7p-value: 0.4709Wilcoxon (Mann-Whitney)
Comparison: Day 14p-value: 0.1406Wilcoxon (Mann-Whitney)
Comparison: Day 28p-value: 0.4291Wilcoxon (Mann-Whitney)
Comparison: Day 60p-value: 0.2704Wilcoxon (Mann-Whitney)
Comparison: Day 90p-value: 0.7564Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus
Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments. A higher score indicates a greater loss of sensation. Evaluator Size=ES, Hand & Dorsal Foot Thresholds=HDFT, Normal=N, Diminished Light Touch=DLT,Diminished Protective Sensation=DPS, Loss of Protective Sensation=LOPS, Deep Pressure Sensation Only=DPSO: ES=1.65 (minimum),HDFT=N;ES=2.36,HDFT=N;ES=2.44,HDFT=N;ES=2.83,HDFT=N;ES=3.22,HDFT=DLT;ES=3.61,HDFT=DLT;ES=3.84,HDFT=DPS;ES=4.08,HDFT=DPS;ES-4.17,HDFT=DPS;ES=4.31,HDFT=DPS;ES=4.56,HDFT=LOPS;ES=4.74,HDFT=LOPS;ES=4.93,HDFT=LOPS;ES=5.07,HDFT=LOPS;ES=5.18,HDFT=LOPS;ES=5.46,HDFT=LOPS;ES=5.88,HDFT=LOPS;ES=6.10,HDFT=LOPS;ES=6.45,HDFT=LOPS;ES=6.65 (maximum),HDFT=DPSO.
Time frame: Days 0 (Baseline), 3, 7, 14, 28, 60, 90
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARTISS | Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus | Day 3 | 0.92 Units on a Scale | Standard Deviation 1.79 |
| ARTISS | Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus | Day 7 | 0.55 Units on a Scale | Standard Deviation 1.37 |
| ARTISS | Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus | Day 14 | 0.78 Units on a Scale | Standard Deviation 1.42 |
| ARTISS | Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus | Day 28 | 0.63 Units on a Scale | Standard Deviation 1.41 |
| ARTISS | Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus | Day 60 | 0.5 Units on a Scale | Standard Deviation 1.26 |
| ARTISS | Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus | Day 90 | 0.38 Units on a Scale | Standard Deviation 0.95 |
| Standard of Care | Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus | Day 60 | 0.3 Units on a Scale | Standard Deviation 1.46 |
| Standard of Care | Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus | Day 3 | 0.89 Units on a Scale | Standard Deviation 1.69 |
| Standard of Care | Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus | Day 28 | 0.53 Units on a Scale | Standard Deviation 1.28 |
| Standard of Care | Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus | Day 7 | 0.73 Units on a Scale | Standard Deviation 1.34 |
| Standard of Care | Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus | Day 90 | 0.19 Units on a Scale | Standard Deviation 1.17 |
| Standard of Care | Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus | Day 14 | 0.54 Units on a Scale | Standard Deviation 1.08 |
Comparison: Day 3p-value: 0.9417Wilcoxon (Mann-Whitney)
Comparison: Day 7p-value: 0.5488Wilcoxon (Mann-Whitney)
Comparison: Day 14p-value: 0.7107Wilcoxon (Mann-Whitney)
Comparison: Day 28p-value: 0.8809Wilcoxon (Mann-Whitney)
Comparison: Day 60p-value: 0.4598Wilcoxon (Mann-Whitney)
Comparison: Day 90p-value: 0.3837Wilcoxon (Mann-Whitney)
Secondary
Number of Fluid Aspiration for Seromas
Number of interventions recorded.
Time frame: Day 0 (Surgery Day) to Day 90
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ARTISS | Number of Fluid Aspiration for Seromas | 5 Interventions | Standard Deviation 4.34 |
| Standard of Care | Number of Fluid Aspiration for Seromas | 3.2 Interventions | Standard Deviation 1.64 |
p-value: 0.5621Wilcoxon (Mann-Whitney)
Secondary
Occurrence of Hematoma
The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of hematoma. A hematoma is a collection of blood outside of a blood vessel.
Time frame: Day 0 (Surgery Day) to Day 90
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ARTISS | Occurrence of Hematoma | 0 Events |
| Standard of Care | Occurrence of Hematoma | 0 Events |
Secondary
Occurrence of Seroma
The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of seroma. A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery. This fluid is composed of blood plasma that has seeped out of ruptured small blood vessels and inflammatory fluid produced by the injured and dying cells.
Time frame: Day 0 (Surgery Day) to Day 90
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ARTISS | Occurrence of Seroma | 8 Events |
| Standard of Care | Occurrence of Seroma | 5 Events |
Secondary
Summary of Numbness Assessment by Visit
Subjects were to be presented with a non-verbal VAS to measure the level of numbness (rating 0 \[no numbness\] to 10 \[complete numbness\]) that the patient experienced at the time of the visit.
Time frame: Day 3, 7, 14, 28, 60, 90
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARTISS | Summary of Numbness Assessment by Visit | Day 3 | 5.16 Score on a Scale | Standard Deviation 3.24 |
| ARTISS | Summary of Numbness Assessment by Visit | Day 7 | 5.50 Score on a Scale | Standard Deviation 2.54 |
| ARTISS | Summary of Numbness Assessment by Visit | Day 14 | 4.45 Score on a Scale | Standard Deviation 2.52 |
| ARTISS | Summary of Numbness Assessment by Visit | Day 28 | 3.25 Score on a Scale | Standard Deviation 1.92 |
| ARTISS | Summary of Numbness Assessment by Visit | Day 60 | 3.37 Score on a Scale | Standard Deviation 1.74 |
| ARTISS | Summary of Numbness Assessment by Visit | Day 90 | 2.85 Score on a Scale | Standard Deviation 1.69 |
| Standard of Care | Summary of Numbness Assessment by Visit | Day 60 | 3.16 Score on a Scale | Standard Deviation 2.29 |
| Standard of Care | Summary of Numbness Assessment by Visit | Day 3 | 6.30 Score on a Scale | Standard Deviation 2.39 |
| Standard of Care | Summary of Numbness Assessment by Visit | Day 28 | 3.42 Score on a Scale | Standard Deviation 2.61 |
| Standard of Care | Summary of Numbness Assessment by Visit | Day 7 | 4.95 Score on a Scale | Standard Deviation 2.21 |
| Standard of Care | Summary of Numbness Assessment by Visit | Day 90 | 2.11 Score on a Scale | Standard Deviation 1.91 |
| Standard of Care | Summary of Numbness Assessment by Visit | Day 14 | 4.35 Score on a Scale | Standard Deviation 2.32 |
Secondary
Summary of Pain Assessment by Visit
Subjects were to be presented with a non-verbal visual analogue scale (VAS) to measure the level of pain (rating 0 \[no pain\] to 10 \[worst possible pain\]) the patient experienced at the site of surgery at the time of the visit.
Time frame: Day 3, 7, 14, 28, 60, 90
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARTISS | Summary of Pain Assessment by Visit | Day 7 | 2.7 Score on a Scale | Standard Deviation 2.11 |
| ARTISS | Summary of Pain Assessment by Visit | Day 3 | 3.68 Score on a Scale | Standard Deviation 2.4 |
| ARTISS | Summary of Pain Assessment by Visit | Day 60 | 0.37 Score on a Scale | Standard Deviation 0.76 |
| ARTISS | Summary of Pain Assessment by Visit | Day 14 | 1.7 Score on a Scale | Standard Deviation 1.53 |
| ARTISS | Summary of Pain Assessment by Visit | Day 90 | 0.3 Score on a Scale | Standard Deviation 0.92 |
| ARTISS | Summary of Pain Assessment by Visit | Day 28 | 1.05 Score on a Scale | Standard Deviation 1.73 |
| Standard of Care | Summary of Pain Assessment by Visit | Day 90 | 0.15 Score on a Scale | Standard Deviation 0.37 |
| Standard of Care | Summary of Pain Assessment by Visit | Day 3 | 4 Score on a Scale | Standard Deviation 2.03 |
| Standard of Care | Summary of Pain Assessment by Visit | Day 7 | 2.8 Score on a Scale | Standard Deviation 1.79 |
| Standard of Care | Summary of Pain Assessment by Visit | Day 14 | 1.7 Score on a Scale | Standard Deviation 1.34 |
| Standard of Care | Summary of Pain Assessment by Visit | Day 28 | 0.37 Score on a Scale | Standard Deviation 0.5 |
| Standard of Care | Summary of Pain Assessment by Visit | Day 60 | 0.3 Score on a Scale | Standard Deviation 0.57 |
Secondary
Time to Drain Removal
The drain was ready to be removed when the drainage volume in a given 24 hour period was \<=30cc.
Time frame: Day 0 (Surgery Day) up to Day 90
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ARTISS | Time to Drain Removal | 6.8 Days | Standard Deviation 7.11 |
| Standard of Care | Time to Drain Removal | 9.55 Days | Standard Deviation 5.82 |
Secondary
Total Volume of Fluid Aspirations for Seromas
Volume of fluid recovered was recorded.
Time frame: Day 0 (Surgery Day) to Day 90
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ARTISS | Total Volume of Fluid Aspirations for Seromas | 226.13 mL | Standard Deviation 157.78 |
| Standard of Care | Total Volume of Fluid Aspirations for Seromas | 152.2 mL | Standard Deviation 150.34 |
p-value: 0.3595Wilcoxon (Mann-Whitney)