Randomized, multicenter, double-blind, and placebo-controlled trial using topical recombinant human acidic fibroblast growth factor for deep partial-thickness burns and skin graft donor site.
Wound healing is a dynamic and complex biologic process that could be accelerated by growth factors. To investigate the efficacy of topical recombinant human acidic fibroblast growth factor (rh-aFGF) treatment in deep partial-thickness burn or skin graft donor sites, we designed a randomized, multicenter, double-blind, and placebo-controlled clinical trial. The healing rate, fully healed rate, and healing time were evaluated to assess the efficacy of rh-aFGF application. Laboratory examinations and abnormal signs were used to assess the side and toxic effects. The results showed that the healing rate of burn wounds and skin graft donor sites treated by rh-aFGF was significantly higher than that by placebo, and the mean healed time of burn wounds and skin graft donor sites in the rh-aFGF group was significantly the shorter than that in the placebo group. In conclusion, topical administration of rh-aFGF can accelerate the wound healing process and shorten the healed time. It is a potential therapeutic application for promoting healing of deep partial-thickness burns or skin graft donor sites.
Ma
Bing
B
Department of Burn Surgery, Changhai Hospital, the Second Military Medical University, Shanghai, China.
Cheng
Da-Sheng
DS
Xia
Zhao-Fan
ZF
Ben
Dao-Feng
DF
Lu
Wei
W
Cao
Zhi-Fang
ZF
Wang
Qiang
Q
He
Jia
J
Chai
Jia-Ke
JK
Shen
Chuan-An
CA
Sun
Yong-Hua
YH
Zhang
Guo-An
GA
Hu
Xiao-Hua
XH
D000287:Administration, Topical; D000328:Adult; D002053:Burn Units; D002056:Burns / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D016222:Fibroblast Growth Factor 2 / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D010919:Placebos; D016038:Skin Transplantation; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*
D010919:Placebos; D016222:Fibroblast Growth Factor 2