NCT01112735CompletedPhase 2
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
Baxter Healthcare Corporation6 sites in 1 country40 target enrollmentStarted: May 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 40
- Locations
- 6
- Primary Endpoint
- Total Drainage Volume Collected Until Drain Removal
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
ARTISS
Experimental
ARTISS will be used as an adjuvant to standard of care.
Intervention: FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma) (Biological)
Standard of care
Other
Standard of care
Intervention: Standard of care (Procedure)
Outcomes
Primary Outcomes
Total Drainage Volume Collected Until Drain Removal
Time Frame: 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 Outcomes
- Number of Fluid Aspiration for Seromas(Day 0 (Surgery Day) to Day 90)
- Total Volume of Fluid Aspirations for Seromas(Day 0 (Surgery Day) to Day 90)
- Occurrence of Seroma(Day 0 (Surgery Day) to Day 90)
- Occurrence of Hematoma(Day 0 (Surgery Day) to Day 90)
- Time to Drain Removal(Day 0 (Surgery Day) up to Day 90)
- Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus(Days 0 (Baseline), 3, 7, 14, 28, 60, 90)
- Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus(Days 0 (Baseline), 3, 7, 14, 28, 60, 90)
- Summary of Pain Assessment by Visit(Day 3, 7, 14, 28, 60, 90)
- Summary of Numbness Assessment by Visit(Day 3, 7, 14, 28, 60, 90)
Investigators
Study Sites (6)
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