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

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 0
• Participant gender: Both

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baxter Healthcare Corporation
• Treatments: Fibrin Tissue Adhesive; Thrombin
• Last Updated: 2008-02-06

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.