The safety and effect of topically applied recombinant basic fibroblast growth factor on the healing of chronic pressure sores

M. C. Robson, L. G. Phillips, W. T. Lawrence, J. B. Bishop, J. S. Youngerman, P. G. Hayward, L. D. Broemeling, J. P. Heggers, J. A. Mannick, I. K. Cohen, P. Friedmann, E. L. Kaplan, M. J. Jurkiewicz, D. Trunkey, W. Silen

Research output: Contribution to journalArticle

206 Scopus citations

Abstract

The first randomized, blinded, placebo-controlled human trials of recombinant basic fibroblast growth factor (bFGF) for pressure sore treatment were performed. Three different concentrations of bFGF in five dosing schedules were tested for safety using hematology, serum chemistries, urinalysis, absorption, antibody formation, and signs of toxicity. Efficacy was evaluated by wound volumes, histology, and photography. No toxicity, significant serum absorption, or antibody formation occurred. In six of eight subgroups, there was a trend toward efficacy with bFGF treatment. When all subgroups were combined, comparison of the slopes of the regression curves of volume decrease over initial pressure sore volume demonstrated a greater healing effect for the bFGF-treated patients (p < 0.05). Histologically, bFGF-treated wound sections demonstrated increased fibroblasts and capillaries. More patients treated with bFGF achieved >70% wound closure (p < 0.05). Blinded observers were able to distinguish differences in visual wound improvement between bFGF and placebo groups. These data suggest that bFGF may be effective in the treatment of chronic wounds.

Original languageEnglish (US)
Pages (from-to)401-408
Number of pages8
JournalAnnals of surgery
Volume216
Issue number4
DOIs
StatePublished - 1992

ASJC Scopus subject areas

  • Surgery

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    Robson, M. C., Phillips, L. G., Lawrence, W. T., Bishop, J. B., Youngerman, J. S., Hayward, P. G., Broemeling, L. D., Heggers, J. P., Mannick, J. A., Cohen, I. K., Friedmann, P., Kaplan, E. L., Jurkiewicz, M. J., Trunkey, D., & Silen, W. (1992). The safety and effect of topically applied recombinant basic fibroblast growth factor on the healing of chronic pressure sores. Annals of surgery, 216(4), 401-408. https://doi.org/10.1097/00000658-199210000-00002