Healing Human Moderate and Large Traumatic Tympanic Membrane Perforations Using Basic Fibroblast Growth Factor, 0.3% Ofloxacin Eardrops, and Gelfoam Patching

Lou, Zhengcai; Lou, Zihan; Liu, Yachao; Chang, Jiang

doi:10.1097/mao.0000000000001080

Cited by 24 publications

(35 citation statements)

References 32 publications

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“…Multiple publications evaluated the use of gelatin‐containing material, which included the terms gelatin sponge, gelatin film, and Gelfoam/Gelfilm (Pfizer, New York, NY) 12,38–46 . The sole study on gelatin film was excluded, as the tympanoplasty procedure included ossiculoplasty 47 .…”

Section: Resultsmentioning

confidence: 99%

A Systematic Review of Nonautologous Graft Materials Used in Human Tympanoplasty

et al. 2020

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Objectives Nonautologous graft materials may solve several dilemmas in tympanoplasty by obviating the need for graft harvest, facilitating consistent wound healing, and permitting graft placement in the clinical setting. Prior studies of nonautologous grafts in humans have shown variable outcomes. In this systematic review, we aim to 1) summarize clinical outcomes and 2) discuss limitations in the literature regarding nonautologous grafts for tympanoplasty in humans. Methods A literature review was performed using the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) recommendations. The study size, etiology and duration of perforation, type of nonautologous graft, and postoperative closure rate were assessed. Results The PRISMA approach yielded 61 articles, including 3,247 ears that met inclusion criteria. Studies evaluated nonautologous grafts including paper patch, gelatin sponge, growth factors, porcine small‐intestinal submucosa, among others. Traumatic perforations (62.3%) were most commonly studied, whereas postinfectious perforations (31.9%) and other etiologies (5.8%) comprised a minority of cases. Acute perforations of <8 weeks duration constituted just over half of all treated ears. Overall closure rate was 82.1%, with significantly higher closure rates in acute (89.9%) versus chronic perforations (64.9%, P < .01), regardless of material. A median postoperative air‐bone gap of 5.6 dB was found in the 23% of studies reporting this metric. Conclusions The majority of publications reviewing nonautologous materials in tympanoplasty evaluate acute or traumatic perforations, and few rigorously report hearing outcomes. Given available data, porcine submucosa and basic fibroblast growth factor may hold promise for chronic perforation closure. Future studies should report closure rates and hearing outcomes in perforations >8 weeks duration. Laryngoscope, 131:392–400, 2021

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Section: Resultsmentioning

confidence: 99%

A Systematic Review of Nonautologous Graft Materials Used in Human Tympanoplasty

et al. 2020

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“…Perforations in three studies (6,13,23) were chronic due to various causes, while perforations in the other studies (7,(14)(15)(16)(17)(18)(19)(20)(21)(22)24) were caused by trauma. All studies reported the closure rates (6,7,(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24); only eight studies reported the healing time (7,15,(18)(19)(20)(21)(22)24). Six studies provided the outcomes of hearing (7,14,15,19,21,24).…”

Section: Characteristics Of the Studiesmentioning

confidence: 96%

“…Of the 91 studies identified, a total of 14 studies with 1,072 patients were included in this meta-analysis, consisting of seven RCTs (7,14,15,17,19,23,24) and seven non-RCTs (6,13,16,18,(20)(21)(22). The included studies were published between 2003 and 2018, with a range of follow-up time from 3 to 12 months.…”

Section: Characteristics Of the Studiesmentioning

confidence: 99%

“…Until recently, a majority of the studies were in animal models. However, in the recent years, we have witnessed a surge in the use of bFGF in human trials (6,7,(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24). Although a majority of trials reported promising benefits, the perforation closure rates varied across the different studies, and there does not appear to be a consensus for hearing benefits.…”

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confidence: 99%

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The Effectiveness of bFGF in the Treatment of Tympanic Membrane Perforations: A Systematic Review and Meta-Analysis

Huang

Teh

Eikelboom

et al. 2020

Otology &Amp; Neurotology

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Objective: To investigate the effectiveness of basic fibroblast growth factor (bFGF) versus placebo or no intervention in the treatment of tympanic membrane (TM) perforations from randomized controlled trials (RCTs), prospective and retrospective studies. Data Sources: PubMed, EMBASE, and Cochrane databases were screened from their inceptions to June 2019. Study Selection: Inclusion criteria: 1) English language; 2) observational (retrospective or prospective) or treatment (RCT) studies; 3) reported the outcomes on the application of bFGF in adult or pediatric population. Exclusion criteria: 1) studies without a control group; 2) animal studies, in vitro studies, review studies, and case reports. Data Extraction: Number of patients, cause of TM perforation, perforation size, treatment, mean age, follow-up time, sex, closure rate, healing time, mean air-bone gap improvement. Data Synthesis: A total of 14 studies were included, including seven RCTs and seven non-RCTs with a total of 1,072 participants. The odds ratio for closure rate of bFGF treatment was 7.33 (95% confidence interval [CI], 4.65 to 11.53; p < 0.01; I 2 ¼ 44%) and the standardized mean difference (SMD) for healing time was-5.89 (95% CI:-7.85 to-3.93, p < 0.01, I 2 ¼ 98%), suggesting bFGF application has a significant effect on closure of TM perforations. However, no significant change in hearing (SMD: 0.08, 95% CI:-0.11 to 0.27, p ¼ 0.39, I 2 ¼ 0%) was seen as a result of bFGF treatment. Conclusions: Our meta-analysis has revealed that the application of bFGF can significantly enhance the closure rate as well as shorten the healing time for TM perforations. In terms of hearing, there is as yet no evidence that bFGF has a significant effect. Given its ease, availability, and safety, bFGF can be used effectively for TM repair.

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“…Indeed, Lou et al found no significant differences in closure rate and mean closure time for traumatic TM perforations treated with high dose (0.25-0.3 mL of a 21,000 IU/5 mL solution) and low dose (0.1-0.15 mL) FGF-2 [21,33]. Significantly, they have also found no difference between the application of FGF-2 and 0.3% ofloxacin eardrops [34]. This led them to speculate that it was the moist eardrum environment afforded by the eardrop applications that might have aided in shortening the closure time and improve the closure rate of large traumatic TM perforations [35].…”

Section: Introductionmentioning

confidence: 96%

Fibroblast Growth Factor 2—A Review of Stabilisation Approaches for Clinical Applications

et al. 2020

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Basic fibroblast growth factor (FGF)-2 has been shown to regulate many cellular functions including cell proliferation, migration, and differentiation, as well as angiogenesis in a variety of tissues, including skin, blood vessel, muscle, adipose, tendon/ligament, cartilage, bone, tooth, and nerve. These multiple functions make FGF-2 an attractive component for wound healing and tissue engineering constructs; however, the stability of FGF-2 is widely accepted to be a major concern for the development of useful medicinal products. Many approaches have been reported in the literature for preserving the biological activity of FGF-2 in aqueous solutions. Most of these efforts were directed at sustaining FGF-2 activity for cell culture research, with a smaller number of studies seeking to develop sustained release formulations of FGF-2 for tissue engineering applications. The stabilisation approaches may be classified into the broad classes of ionic interaction modification with excipients, chemical modification, and physical adsorption and encapsulation with carrier materials. This review discusses the underlying causes of FGF-2 instability and provides an overview of the approaches reported in the literature for stabilising FGF-2 that may be relevant for clinical applications. Although efforts have been made to stabilise FGF-2 for both in vitro and in vivo applications with varying degrees of success, the lack of comprehensive published stability data for the final FGF-2 products represents a substantial gap in the current knowledge, which has to be addressed before viable products for wider tissue engineering applications can be developed to meet regulatory authorisation.

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Healing Human Moderate and Large Traumatic Tympanic Membrane Perforations Using Basic Fibroblast Growth Factor, 0.3% Ofloxacin Eardrops, and Gelfoam Patching

Cited by 24 publications

References 32 publications

A Systematic Review of Nonautologous Graft Materials Used in Human Tympanoplasty

A Systematic Review of Nonautologous Graft Materials Used in Human Tympanoplasty

The Effectiveness of bFGF in the Treatment of Tympanic Membrane Perforations: A Systematic Review and Meta-Analysis

Fibroblast Growth Factor 2—A Review of Stabilisation Approaches for Clinical Applications

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