Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Controlled, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of ARTISS (FS VH S/D 4 S-apr) for Flap Adherence in Subjects Undergoing Abdominoplasty

Conditions
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Seroma, Hematoma

Intervention / Treatment
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* Biological: FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)
* Procedure: Standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARTISS<br>ARTISS will be used as an adjuvant to standard of care. | Biological: FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)<br>* Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed.<br>* Other names: ARTISS;|
| Other: Standard of care<br>Standard of care | Procedure: Standard of care<br>* Standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 0 (Surgery Day) to Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 0 (Surgery Day) to Day 90 | 
| 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. | Day 0 (Surgery Day) to Day 90 | 
| Time to Drain Removal | The drain was ready to be removed when the drainage volume in a given 24 hour period was <=30cc. | Day 0 (Surgery Day) up to Day 90 | 
| Number of Fluid Aspiration for Seromas | Number of interventions recorded. | Day 0 (Surgery Day) to Day 90 | 
| Total Volume of Fluid Aspirations for Seromas | Volume of fluid recovered was recorded. | Day 0 (Surgery Day) to Day 90 | 
| 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. | Days 0 (Baseline), 3, 7, 14, 28, 60, 90 | 
| 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. | Days 0 (Baseline), 3, 7, 14, 28, 60, 90 | 
| 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. | Day 3, 7, 14, 28, 60, 90 | 
| 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. | Day 3, 7, 14, 28, 60, 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominoplasty, Flap adherence in subjects undergoing abdominoplasty to eliminate dead space and reduce seroma/hematoma formation