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.

First Received: September 8, 2005 Last Updated: February 6, 2008 History of Changes

Sponsored by:	Baxter Healthcare Corporation
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00157131

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 III

MedlinePlus related topics: Burns

Drug Information available for: Beriplast Fibrin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

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
Shriners Hospitals for Children, Northern Calif.
Sacramento, California, United States, 95817
UCSD Medical Center
San Diego, California, United States, 92103-8896
UCI Medical Center
Orange, California, United States, 92868-3298
United States, Florida
University of Florida/ Shands Hospital
Gainesville, Florida, United States, 32610
United States, Illinois
SIU School of Medicine
Springfield, Illinois, United States, 62702-9653
Director of Burn & Shock Trauma Institute
Maywood, Illinois, United States, 60153
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

Study ID Numbers:	550201
Study First Received:	September 8, 2005
Last Updated:	February 6, 2008
ClinicalTrials.gov Identifier:	NCT00157131 History of Changes
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

Study placed in the following topic categories:

Thrombin
Burns
Fibrin Tissue Adhesive
Hemostatics

Additional relevant MeSH terms:

Coagulants
Fibrin Tissue Adhesive
Therapeutic Uses

Hematologic Agents
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on May 06, 2009