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Safety and efficacy of basic fibroblast growth factors for deep second–degree burn patients

Authors
Ahn, H.-NKang, H.-S.Park, S.-J.Park, M.-H.Chun, W.Cho, Eun
Issue Date
Dec-2020
Publisher
Elsevier Ltd
Keywords
Adverse event; Basic fibroblast growth factor; Post-marketing surveillance; Regenerative medicine; Second–degree burn
Citation
Burns, v.46, no.8, pp.1857 - 1866
Journal Title
Burns
Volume
46
Number
8
Start Page
1857
End Page
1866
URI
https://scholarworks.sookmyung.ac.kr/handle/2021.sw.sookmyung/814
DOI
10.1016/j.burns.2020.06.019
ISSN
0305-4179
Abstract
Introduction: Burn injuries are common afflictions; however, conservative wound care frequently leads to poor treatment compliance and physical disability in deep burn patients. Therefore, regenerative biologic materials, which are more effective for tissue repair, are required, particularly for deep second-degree burns. A novel spray formulation of basic fibroblast growth factors (bFGF) was produced by synthesizing fibroblast growth factor proteins. In this post-marketing surveillance (PMS) study, we assessed the safety and efficacy of bFGF and indirectly compared this formulation with cultured epidermal autografts (CEAs) for treating deep second-degree burns. Materials and methods: A total of 3173 patients treated at 15 hospitals were used for PMS of bFGF in South Korea for six years. In total, 1630 patients with deep second–degree burns were selected for assessing adverse events (AEs) of bFGF treatments. Efficacy was evaluated according to time periods until re-epithelialization, and clinical usefulness of bFGF was indirectly compared with that of CEAs. Results: AEs occurred in 37 patients (2.3%) and included application site pain (1.7%) and contact dermatitis (0.6%). All AEs were mild and were evaluated as probably unrelated with bFGF. The average time for re-epithelialization was 8 days; this time span was significantly longer after major burns (9.7 days) than after minor (7.8 days) or moderate burns (7.9 days). Most treated burn wounds (99.8%) were assessed as improved. The indirect comparison included 534 patients using the same inclusion criteria for CEA patients (n = 35). The bFGF treatment demonstrated superior efficacy compared to CEAs by significantly reducing the average day to application (5.4 vs. 8.8 days) and re-epithelialization time (7.1 vs. 13.7 days). Conclusion: Our study demonstrated that bFGF is a compelling regenerative therapy with competitive clinical efficacy and safety for deep second–degree burns and reduced treatment time, which is expected to reduce medical costs, particularly for deep second–degree burn patients. © 2020 Elsevier Ltd and ISBI
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