Safety and Efficacy Study of FS 4 IU VH S/D (Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent/Detergent Treated) to Adhere Split Thickness Skin Grafts and Improve Wound Healing in Burn Patients

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: NCT00157131
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : April 20, 2017
Information provided by:
Baxter Healthcare Corporation

Brief Summary:
The primary objective of this study is to evaluate skin graft adherence and wound healing in burn patients to evaluate whether FS 4IU VH S/D is equivalent or superior to the current standard of care (staples). The primary endpoint is achievement of complete (100%) wound closure within 28 days.

Condition or disease Intervention/treatment Phase
Deep Partial or Full Thickness Wounds Biological: Fibrin Sealant, ARTISS 4IU/ml VH SD Other: Staples Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study To Evaluate the Safety and Efficacy of Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS 4IU VH S/D) to Adhere Tissues and Improve Wound Healing
Study Start Date : June 2004
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: FS 4IU VH S/D
FS 4IU VH S/D was administered intraoperatively to the wound bed by spray application using the TISSOMAT and Spray Set. Only the DUPLOJECTvii system and Spray Set (connection tube with sterile filter and spray head) device was used for simultaneous spray application of the study product. A thin layer of FS 4IU VH S/D was applied to the wound bed using a "painting motion" from side to side to achieve coverage. The recommended dosing volume was 2.0 to 4.0 mL/100 cm2. One 2-mL pack (4 mL total volume) of FS 4IU VH S/D applied using the TISSOMAT and Spray Set was sufficient to coat a wound bed of 100-200 cm2.
Biological: Fibrin Sealant, ARTISS 4IU/ml VH SD
FS 4IU VH S/D, a two-component fibrin sealant with 4 IU/mL human thrombin, vapor heated, solvent detergent treated, provided in a frozen, ready-to-use formulation. Administration by a topical spray application using the TISSOMAT device and Spray Set.
Active Comparator: Staples
Staples are the current standard of care in burn surgery and are well accepted as the control in this type of study.
Other: Staples
Administration by mechanical/multiple point fixation.

Primary Outcome Measures :
  1. Complete wound closure by Day 28 after treatment with either FS 4IU VH S/D or staples as determined by a blinded independent review of the Day 28 photographs [ Time Frame: 28 days after treatment ]
  2. Adverse experiences (AEs) deemed possibly or probably related to treatment with FS 4IU VH S/D [ Time Frame: 12 months after treatment ]

Secondary Outcome Measures :
  1. Presence of hematoma/seroma on Day 1 [ Time Frame: 1 day after treatment ]
  2. Percent area of hematoma/seroma on Day 1 [ Time Frame: 1 day after treatment ]
  3. 100% engraftment by Day 5 [ Time Frame: 5 days after treatment ]
  4. Percent area of engraftment on Day 5 [ Time Frame: 5 days after treatment ]
  5. Complete wound closure by Day 14 [ Time Frame: 14 days after treatment ]
  6. Percent area of closure by Days 14 and 28 [ Time Frame: 14 and 28 days after treatment ]
  7. Scar maturation assessed by blinded Vancouver Scar Scale evaluations on Months 3, 6, 9, and 12 [ Time Frame: 3, 6, 9, and 12 months after treatment ]

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Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects or their legal representatives, who have read, understood and signed a written informed consent.
  • Subjects of either sex.
  • Female subjects of childbearing potential with a negative urine or serum pregnancy test on admission.
  • Subjects who are <= 65 years of age including pediatric subjects of all ages.
  • Subjects with total burn wounds measuring <= 40% TBSA.
  • Subjects with a contiguous deep partial thickness/full thickness wound, between 2% and 8% TBSA or two comparable, bilateral wounds each measuring between 1% and 4% TBSA.
  • Wounds designated as test sites require autologous sheet skin grafts with a thickness of 8/1000" - 16/1000"
  • Subjects who are able, and willing to comply with the procedures required by the protocol.

Exclusion Criteria:

  • Subjects with electrical burns.
  • Subjects with chemical burns
  • Digits and genitalia are excluded as test sites.
  • Subjects with infection at test area/test sites.
  • Subjects with test sites previously randomized and treated in this study.
  • Subjects with venous or arterial vascular disorder that directly affects a designated test area/test site.
  • Subjects with pre-existing hemolytic anemia
  • Subjects with diabetes mellitus.
  • Subjects with documented history of pathologically or pharmacologically induced immune deficiency.
  • Subjects judged to be chronically malnourished.
  • Subjects that are judged to have significant pulmonary compromise.
  • Subjects receiving systemic corticosteroids within 30 days prior to skin grafting (not including inhaled steroids).
  • Subjects with known or suspected hypersensitivity to bovine proteins.
  • Subjects participating in another clinical trial that is evaluating an unapproved drug or device.

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): NCT00157131

United States, Alabama
Birmingham, Alabama, United States
Mobile, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, California
Orange, California, United States
Sacramento, California, United States
San Diego, California, United States
United States, Florida
Gainesville, Florida, United States
United States, Illinois
Maywood, Illinois, United States
Springfield, Illinois, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Nebraska
Lincoln, Nebraska, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Allentown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
United States, Texas
Lubbock, Texas, United States
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
Baxter Healthcare Corporation
Principal Investigator: David Greenhalgh, MD Shriners Hospitals for Children, Northern Calif.

Publications of Results: Identifier: NCT00157131     History of Changes
Other Study ID Numbers: 550201
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by Baxter Healthcare Corporation:
autologous sheet skin grafts
skin grafts

Additional relevant MeSH terms:
Wounds and Injuries
Fibrin Tissue Adhesive