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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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00157131
First received: September 8, 2005
Last updated: April 19, 2017
Last verified: April 2017
  Purpose
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 Intervention Phase
Deep Partial or Full Thickness Wounds Biological: Fibrin Sealant, ARTISS 4IU/ml VH SD Other: Staples Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • 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 ]
  • 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:
  • Presence of hematoma/seroma on Day 1 [ Time Frame: 1 day after treatment ]
  • Percent area of hematoma/seroma on Day 1 [ Time Frame: 1 day after treatment ]
  • 100% engraftment by Day 5 [ Time Frame: 5 days after treatment ]
  • Percent area of engraftment on Day 5 [ Time Frame: 5 days after treatment ]
  • Complete wound closure by Day 14 [ Time Frame: 14 days after treatment ]
  • Percent area of closure by Days 14 and 28 [ Time Frame: 14 and 28 days after treatment ]
  • 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 ]

Enrollment: 150
Study Start Date: June 2004
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157131

Locations
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
Investigators
Principal Investigator: David Greenhalgh, MD Shriners Hospitals for Children, Northern Calif.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00157131     History of Changes
Other Study ID Numbers: 550201
Study First Received: September 8, 2005
Last Updated: April 19, 2017

Keywords provided by Baxter Healthcare Corporation:
autologous sheet skin grafts
FS 4IU VH S/D
skin grafts
burn

Additional relevant MeSH terms:
Wounds and Injuries
Fibrin Tissue Adhesive
Thrombin
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on June 29, 2017