Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty - Full Text View

Purpose

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.

Condition	Intervention	Phase
Seroma Hematoma	Biological: FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma) Procedure: Standard of care	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
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

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

Effect of ARTISS on the improvement of flap adherence in subjects undergoing abdominoplasty, as indicated by a reduction in drainage volume [ Time Frame: 90 days (per subject) ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	May 2010
Study Completion Date:	February 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ARTISS 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) Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed. Other Name: ARTISS
Standard of care Standard of care	Procedure: Standard of care Standard of care

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112735

Locations

United States, California
Mei Li Surgery Center
Beverly Hills, California, United States, 90210
United States, Florida
Center for Plastic Surgery and Skin Care
Fort Lauderdale, Florida, United States, 33308
Miami Plastic Surgery
Miami, Florida, United States, 33176
United States, Georgia
Places Plastic Surgery
Atlanta, Georgia, United States, 30327
United States, Illinois
The Practice of Gary Wiesman, M.D. and Irvin Wiesman, M.D. and Associates
Chicago, Illinois, United States, 60654
United States, Texas
UT Southwestern Medical Center, Department of Plastic Surgery
Dallas, Texas, United States, 75390-9132

Sponsors and Collaborators

Baxter Healthcare Corporation

Investigators

Study Director:

Steve Z Abrams, MD, MBA

Baxter Healthcare Corporation

More Information

No publications provided

Responsible Party:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT01112735 History of Changes
Other Study ID Numbers:	550902
Study First Received:	April 27, 2010
Last Updated:	February 3, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Baxter Healthcare Corporation:

Abdominoplasty
Flap adherence in subjects undergoing abdominoplasty to eliminate dead space and reduce seroma/hematoma formation

Additional relevant MeSH terms:

Hematoma
Seroma
Hemorrhage
Pathologic Processes
Inflammation
Fibrin Tissue Adhesive

Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013