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Topical fibroblast growth factor‐2 for treatment of chronic tympanic membrane perforations
OBJECTIVE: To determine the efficacy of fibroblast growth factor‐2 (FGF‐2) in treating chronic nonhealing tympanic membrane (TM) perforations. METHOD: Double‐blinded, randomized placebo controlled phase 2 clinical trial for patients with chronic TM perforations of more than 3 months duration with a...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons, Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7444771/ https://www.ncbi.nlm.nih.gov/pubmed/32864435 http://dx.doi.org/10.1002/lio2.395 |
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author | Santos, Felipe Shu, Edina Lee, Daniel J. Jung, David H. Quesnel, Alicia M. Stankovic, Konstantina M. Abdul‐Aziz, Dunia E. Bay, Camden P. Quinkert, Amy Welling, D. Bradley |
author_facet | Santos, Felipe Shu, Edina Lee, Daniel J. Jung, David H. Quesnel, Alicia M. Stankovic, Konstantina M. Abdul‐Aziz, Dunia E. Bay, Camden P. Quinkert, Amy Welling, D. Bradley |
author_sort | Santos, Felipe |
collection | PubMed |
description | OBJECTIVE: To determine the efficacy of fibroblast growth factor‐2 (FGF‐2) in treating chronic nonhealing tympanic membrane (TM) perforations. METHOD: Double‐blinded, randomized placebo controlled phase 2 clinical trial for patients with chronic TM perforations of more than 3 months duration with a cross‐over arm. Patients received either FGF‐2 or placebo (sterile water) saturated gelatin sponge in the perforation after rimming the perforation under topical anesthesia. The perforation was then covered with Tisseel fibrin glue. The primary endpoint was complete closure of the TM perforation. Secondary end points included change in hearing and partial TM closure rates. The TM was examined every 3 weeks with otoendoscopy for closure. The treatment was repeated if there was incomplete closure every 3 weeks up to a total of three treatments per arm. RESULTS: Seventy four patients were recruited for the study. Fifty seven met eligibility criteria and fifty four completed the study. Ten of 14 perforations closed completely in the placebo group (71.4%) and 23 of 40 perforations closed completely in the FGF‐2 treatment group (57.5%), P value = .36. Pure tone averages and word recognition scores were not statistically significantly different between study groups post‐treatment. After initial complete closure, re‐perforation occurred in seven FGF‐2 treated patients and two placebo patients making the effective final closure rate 40% for FGF and 57% for placebo, respectively. CONCLUSION: No statistically significant difference in tympanic membrane perforation closure rate was found between the FGF‐2 and placebo groups. There were no differences in hearing outcomes between the groups. LEVEL OF EVIDENCE: 1b. |
format | Online Article Text |
id | pubmed-7444771 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley & Sons, Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-74447712020-08-28 Topical fibroblast growth factor‐2 for treatment of chronic tympanic membrane perforations Santos, Felipe Shu, Edina Lee, Daniel J. Jung, David H. Quesnel, Alicia M. Stankovic, Konstantina M. Abdul‐Aziz, Dunia E. Bay, Camden P. Quinkert, Amy Welling, D. Bradley Laryngoscope Investig Otolaryngol Comprehensive (General) Otolaryngology OBJECTIVE: To determine the efficacy of fibroblast growth factor‐2 (FGF‐2) in treating chronic nonhealing tympanic membrane (TM) perforations. METHOD: Double‐blinded, randomized placebo controlled phase 2 clinical trial for patients with chronic TM perforations of more than 3 months duration with a cross‐over arm. Patients received either FGF‐2 or placebo (sterile water) saturated gelatin sponge in the perforation after rimming the perforation under topical anesthesia. The perforation was then covered with Tisseel fibrin glue. The primary endpoint was complete closure of the TM perforation. Secondary end points included change in hearing and partial TM closure rates. The TM was examined every 3 weeks with otoendoscopy for closure. The treatment was repeated if there was incomplete closure every 3 weeks up to a total of three treatments per arm. RESULTS: Seventy four patients were recruited for the study. Fifty seven met eligibility criteria and fifty four completed the study. Ten of 14 perforations closed completely in the placebo group (71.4%) and 23 of 40 perforations closed completely in the FGF‐2 treatment group (57.5%), P value = .36. Pure tone averages and word recognition scores were not statistically significantly different between study groups post‐treatment. After initial complete closure, re‐perforation occurred in seven FGF‐2 treated patients and two placebo patients making the effective final closure rate 40% for FGF and 57% for placebo, respectively. CONCLUSION: No statistically significant difference in tympanic membrane perforation closure rate was found between the FGF‐2 and placebo groups. There were no differences in hearing outcomes between the groups. LEVEL OF EVIDENCE: 1b. John Wiley & Sons, Inc. 2020-05-14 /pmc/articles/PMC7444771/ /pubmed/32864435 http://dx.doi.org/10.1002/lio2.395 Text en © 2020 The Authors. Laryngoscope Investigative Otolaryngology published by Wiley Periodicals, Inc. on behalf of The Triological Society. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Comprehensive (General) Otolaryngology Santos, Felipe Shu, Edina Lee, Daniel J. Jung, David H. Quesnel, Alicia M. Stankovic, Konstantina M. Abdul‐Aziz, Dunia E. Bay, Camden P. Quinkert, Amy Welling, D. Bradley Topical fibroblast growth factor‐2 for treatment of chronic tympanic membrane perforations |
title | Topical fibroblast growth factor‐2 for treatment of chronic tympanic membrane perforations |
title_full | Topical fibroblast growth factor‐2 for treatment of chronic tympanic membrane perforations |
title_fullStr | Topical fibroblast growth factor‐2 for treatment of chronic tympanic membrane perforations |
title_full_unstemmed | Topical fibroblast growth factor‐2 for treatment of chronic tympanic membrane perforations |
title_short | Topical fibroblast growth factor‐2 for treatment of chronic tympanic membrane perforations |
title_sort | topical fibroblast growth factor‐2 for treatment of chronic tympanic membrane perforations |
topic | Comprehensive (General) Otolaryngology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7444771/ https://www.ncbi.nlm.nih.gov/pubmed/32864435 http://dx.doi.org/10.1002/lio2.395 |
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