Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01112735
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : February 7, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : May 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : February 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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) ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01112735

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
Study Director: Steve Z Abrams, MD, MBA Baxter Healthcare Corporation

Responsible Party: Baxter Healthcare Corporation Identifier: NCT01112735     History of Changes
Other Study ID Numbers: 550902
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 2012

Keywords provided by Baxter Healthcare Corporation:
Flap adherence in subjects undergoing abdominoplasty to eliminate dead space and reduce seroma/hematoma formation

Additional relevant MeSH terms:
Pathologic Processes
Fibrin Tissue Adhesive