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Sponsored by: |
Baxter Healthcare Corporation |
---|---|
Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00157131 |
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 |
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 |
Ages Eligible for Study: | up to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | David Greenhalgh, MD | Shriners Hospitals for Children, Northern Calif. |
Study ID Numbers: | 550201 |
Study First Received: | September 8, 2005 |
Last Updated: | February 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00157131 |
Health Authority: | United States: Food and Drug Administration |
autologous sheet skin grafts FS 4IU VH S/D skin grafts burn |
Thrombin Burns Fibrin Tissue Adhesive |
Coagulants Therapeutic Uses Hematologic Agents Pharmacologic Actions Hemostatics |