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: February 6, 2008
Last verified: February 2008
  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
Drug: Fibrin Sealant, Tisseel 4IU/ml VH SD
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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:

Study Start Date: June 2004
Study Completion Date: September 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
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
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35292
University of South Alabama
Mobile, Alabama, United States, 36617
United States, Arizona
Maricopa Medical Center
Phoenix, Arizona, United States, 85008
United States, California
UCI Medical Center
Orange, California, United States, 92868-3298
Shriners Hospitals for Children, Northern Calif.
Sacramento, California, United States, 95817
UCSD Medical Center
San Diego, California, United States, 92103-8896
United States, Florida
University of Florida/ Shands Hospital
Gainesville, Florida, United States, 32610
United States, Illinois
Director of Burn & Shock Trauma Institute
Maywood, Illinois, United States, 60153
SIU School of Medicine
Springfield, Illinois, United States, 62702-9653
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, Nebraska
St. Elizabeth Regional Medical Center
Lincoln, Nebraska, United States, 68510
United States, Ohio
Shriners Hospitals for Children
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430-8183
United States, Washington
University of Washington Burn Center
Seattle, Washington, United States, 98104
United States, Wisconsin
University of Wisconsin Hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: David Greenhalgh, MD Shriners Hospitals for Children, Northern Calif.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00157131     History of Changes
Other Study ID Numbers: 550201
Study First Received: September 8, 2005
Last Updated: February 6, 2008
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014