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Comparison of Fibrin Sealant and Staples for Attaching Split-Thickness Autologous Sheet Grafts in Patients With Deep Partial- or Full-Thickness Burn Wounds: A Phase 1/2 Clinical Study

Gibran, Nicole MD*; Luterman, Arnold MD†; Herndon, David MD‡; Lozano, Daniel MD§; Greenhalgh, David G. MD¶; Grubbs, Lisa∥; Schofield, Neil PhD∥; Hantak, Edith DVM**; Callahan, Janice D. PhD††; Schiestl, Nina MD**; Riina, Louis H. MD‡‡; the FS 4IU Clinical Study Group

Journal of Burn Care & Research: May/June 2007 - Volume 28 - Issue 3 - pp 401-408
doi: 10.1097/BCR.0B013E318053D389
Original Articles

We undertook a multicenter, randomized, controlled, phase 1/2 clinical study to investigate the safety and efficacy of a fibrin sealant containing 4 IU/ml thrombin (FS 4IU) for the attachment of autologous sheet grafts in patients with deep partial-thickness or full-thickness burn wounds. Fibrin sealant (FS 4IU) was compared with staples for adherence of sheet grafts in 40 patients. Patients had to have burn wounds measuring 40% TBSA or less with two comparable test sites measuring between 1% and 4% TBSA each. Wound beds were prepared before treatment assignment, which was randomized. Percent area of hematoma/seroma at Day 1 (P = .0138) and questionable viability at Day 5 (P = .0182) were significantly less for FS 4IU-treated sites. Median percent area of graft survival on Day 14 was 100% for both treatments (P = .3525). The percentage of completely closed sites generally was greater for FS 4IU-sites on Days 5 to 91; the maximum difference occurred at Day 28 (79.5% vs 59%; P = .0215). The safety profile of FS 4IU was excellent as indicated by the lack of any related serious adverse experiences. These findings indicate that FS 4IU is safe and effective for fixation of skin grafts, with outcomes similar to or better than staple fixation. The data suggest that FS 4IU is a promising candidate for further clinical studies focusing on skin graft adhesion and burn wound healing.

From the *University of Washington Burn Center, Seattle, Washington; †University of South Alabama, Mobile, Alabama; ‡Shriner's Hospital for Children, Galveston, Texas; §Lehigh Valley Regional Burn Center, Allentown, Pennsylvania; ¶University of California at Davis/Shriner's Hospital for Children, Sacramento, California; ∥Baxter Healthcare Corporation, Westlake Village, California; **Baxter AG. Vienna, Austria; ††Callahan Associates Inc., San Diego, California; and ‡‡Nassau University Medical Center, Long Island, New York.

Address correspondence to Nina Schiestl, MD, Baxter AG, Baxter BioSurgery, Wagramer Strasse 17-19, IZD Tower, A-1220 Vienna, Austria.

Drs. Gibran, Luterman, Herndon, Lozano, and Greenhalgh are burn surgeons who were clinical investigators on this study and contributed to the writing of the manuscript. All investigators completed financial disclosures per U.S. 21 Code of Federal Regulations Part 54. No conflicts of interest were reported for any of the investigators named on the manuscript. Baxter Healthcare Corporation (Westlake Village, California) was the sponsor and paid all costs associated with the administration of this clinical study. Edith Hantak, Nina Schiestl, Lisa Grubbs, and Neil Schofield are all paid employees of Baxter Healthcare Corporation, were involved in the conduct of this study, and were participants in the writing of the manuscript. Dr Callahan was responsible for the statistical analysis as a paid consultant for this study. Dr Riina is a practicing burn surgeon and a paid consultant of Baxter; he was integrally involved in the study design but was not a data-collecting investigator in this study.

© 2007 The American Burn Association