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

Nicole Gibran, Arnold Luterman, David Herndon, Daniel Lozano, David G. Greenhalgh, Lisa Grubbs, Neil Schofield, Edith Hantak, Janice D. Callahan, Nina Schiestl, Louis H. Riina, Marianne Cinat, Kevin Foster, Richard L. Gamelli, Sidney F. Miller

Research output: Contribution to journalArticle

31 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)401-408
Number of pages8
JournalJournal of Burn Care and Research
Volume28
Issue number3
DOIs
StatePublished - May 1 2007

ASJC Scopus subject areas

  • Surgery
  • Emergency Medicine
  • Rehabilitation

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    Gibran, N., Luterman, A., Herndon, D., Lozano, D., Greenhalgh, D. G., Grubbs, L., Schofield, N., Hantak, E., Callahan, J. D., Schiestl, N., Riina, L. H., Cinat, M., Foster, K., Gamelli, R. L., & Miller, S. F. (2007). 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. Journal of Burn Care and Research, 28(3), 401-408. https://doi.org/10.1097/BCR.0B013E318053D389