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

Martin C. Robson, Linda Phillips, W. Thomas Lawrence, Jon B. Bishop, Jordan S. Youngerman, Peter G. Hayward, Lyle D. Broemeling, John P. Heggers

Research output: Contribution to journalArticle

201 Citations (Scopus)

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)401-406
Number of pages6
JournalAnnals of Surgery
Volume216
Issue number4
StatePublished - 1992

Fingerprint

Pressure Ulcer
Fibroblast Growth Factor 2
Safety
Wounds and Injuries
Antibody Formation
Placebos
Urinalysis
Photography
Hematology
Serum
Histology
Appointments and Schedules
Therapeutics

ASJC Scopus subject areas

  • Surgery

Cite this

Robson, M. C., Phillips, L., Thomas Lawrence, W., Bishop, J. B., Youngerman, J. S., Hayward, P. G., ... Heggers, J. P. (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), 401-406.

The safety and effect of topically applied recombinant basic fibroblast growth factor on the healing of chronic pressure sores. / Robson, Martin C.; Phillips, Linda; Thomas Lawrence, W.; Bishop, Jon B.; Youngerman, Jordan S.; Hayward, Peter G.; Broemeling, Lyle D.; Heggers, John P.

In: Annals of Surgery, Vol. 216, No. 4, 1992, p. 401-406.

Research output: Contribution to journalArticle

Robson, MC, Phillips, L, Thomas Lawrence, W, Bishop, JB, Youngerman, JS, Hayward, PG, Broemeling, LD & Heggers, JP 1992, 'The safety and effect of topically applied recombinant basic fibroblast growth factor on the healing of chronic pressure sores', Annals of Surgery, vol. 216, no. 4, pp. 401-406.
Robson, Martin C. ; Phillips, Linda ; Thomas Lawrence, W. ; Bishop, Jon B. ; Youngerman, Jordan S. ; Hayward, Peter G. ; Broemeling, Lyle D. ; Heggers, John P. / The safety and effect of topically applied recombinant basic fibroblast growth factor on the healing of chronic pressure sores. In: Annals of Surgery. 1992 ; Vol. 216, No. 4. pp. 401-406.
@article{c79d3f8c8fe2416f9a64828ccab7f9b6,
title = "The safety and effect of topically applied recombinant basic fibroblast growth factor on the healing of chronic pressure sores",
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.",
author = "Robson, {Martin C.} and Linda Phillips and {Thomas Lawrence}, W. and Bishop, {Jon B.} and Youngerman, {Jordan S.} and Hayward, {Peter G.} and Broemeling, {Lyle D.} and Heggers, {John P.}",
year = "1992",
language = "English (US)",
volume = "216",
pages = "401--406",
journal = "Annals of Surgery",
issn = "0003-4932",
publisher = "Lippincott Williams and Wilkins",
number = "4",

}

TY - JOUR

T1 - The safety and effect of topically applied recombinant basic fibroblast growth factor on the healing of chronic pressure sores

AU - Robson, Martin C.

AU - Phillips, Linda

AU - Thomas Lawrence, W.

AU - Bishop, Jon B.

AU - Youngerman, Jordan S.

AU - Hayward, Peter G.

AU - Broemeling, Lyle D.

AU - Heggers, John P.

PY - 1992

Y1 - 1992

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=0026786815&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0026786815&partnerID=8YFLogxK

M3 - Article

C2 - 1417189

AN - SCOPUS:0026786815

VL - 216

SP - 401

EP - 406

JO - Annals of Surgery

JF - Annals of Surgery

SN - 0003-4932

IS - 4

ER -