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.
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.
Gibran
Nicole
N
University of Washington Burn Center, Seattle, Washington, USA.
Luterman
Arnold
A
Herndon
David
D
Lozano
Daniel
D
Greenhalgh
David G
DG
Grubbs
Lisa
L
Schofield
Neil
N
Hantak
Edith
E
Callahan
Janice D
JD
Schiestl
Nina
N
Riina
Louis H
LH
D000293:Adolescent; D000328:Adult; D000368:Aged; D002056:Burns / Q000601:surgery*; D002648:Child; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000009:adverse effects / Q000627:therapeutic use*; D006085:Graft Survival; D006801:Humans; D008297:Male; D008875:Middle Aged; D016038:Skin Transplantation / Q000379:methods*; D013537:Sutures; D013917:Thrombin / Q000009:adverse effects / Q000627:therapeutic use*; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014945:Wound Healing
D015718:Fibrin Tissue Adhesive; D013917:Thrombin