Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty

Phase 2

Completed

Conditions: Seroma
Hematoma

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

Registration Number: NCT01112735

Lead Sponsor: Baxter Healthcare Corporation

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARTISS	FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)	ARTISS will be used as an adjuvant to standard of care.
Standard of care	Standard of care	Standard of care

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (6): UT Southwestern Medical Center, Department of Plastic Surgery
🇺🇸
Dallas, Texas, United States
Mei Li Surgery Center
🇺🇸
Beverly Hills, California, United States
Center for Plastic Surgery and Skin Care
🇺🇸
Fort Lauderdale, Florida, United States
Places Plastic Surgery
🇺🇸
Atlanta, Georgia, United States
Miami Plastic Surgery
🇺🇸
Miami, Florida, United States
The Practice of Gary Wiesman, M.D. and Irvin Wiesman, M.D. and Associates
🇺🇸
Chicago, Illinois, United States