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

Completed · Phase 3

Conditions studied: Deep Partial or Full Thickness Wounds

In brief

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.

Key facts

Study ID

NCT00157131

Run by

Baxter Healthcare Corporation

People needed

150

Starts

2004-06-01

Expected to finish

2007-02-01

Last updated by the study team

2017-04-20

Who can join

Age: any, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Orange, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Gainesville, Florida, United States
• Study site — Maywood, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Allentown, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Lubbock, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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