Clinical trial NCT01112735: Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seroma
Hematoma
Keywords: Abdominoplasty
Flap adherence in subjects undergoing abdominoplasty to eliminate dead space and reduce seroma/hematoma formation
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2010-04-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total Drainage Volume Collected Until Drain Removal
timeFrame: Day 0 (Surgery Day) to Day 90
Secondary outcomes:
measure: Occurrence of Seroma
timeFrame: Day 0 (Surgery Day) to Day 90
measure: Occurrence of Hematoma
timeFrame: Day 0 (Surgery Day) to Day 90
measure: Time to Drain Removal
timeFrame: Day 0 (Surgery Day) up to Day 90
measure: Number of Fluid Aspiration for Seromas
timeFrame: Day 0 (Surgery Day) to Day 90
measure: Total Volume of Fluid Aspirations for Seromas
timeFrame: Day 0 (Surgery Day) to Day 90
measure: Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus
timeFrame: Days 0 (Baseline), 3, 7, 14, 28, 60, 90
measure: Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus
timeFrame: Days 0 (Baseline), 3, 7, 14, 28, 60, 90
measure: Summary of Pain Assessment by Visit
timeFrame: Day 3, 7, 14, 28, 60, 90
measure: Summary of Numbness Assessment by Visit
timeFrame: Day 3, 7, 14, 28, 60, 90
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Mei Li Surgery Center
state: California
city: Fort Lauderdale
country: United States
facility: Center for Plastic Surgery and Skin Care
state: Florida
city: Miami
country: United States
facility: Miami Plastic Surgery
state: Florida
city: Atlanta
country: United States
facility: Places Plastic Surgery
state: Georgia
city: Chicago
country: United States
facility: The Practice of Gary Wiesman, M.D. and Irvin Wiesman, M.D. and Associates
state: Illinois
city: Dallas
country: United States
facility: UT Southwestern Medical Center, Department of Plastic Surgery
state: Texas
Study officials:
affiliation: Baxter Healthcare Corporation
name: Steve Z Abrams, MD, MBA
role: STUDY_DIRECTOR
References: