Healing outcomes of large (>50%) traumatic membrane perforations with inverted edges following no intervention, edge approximation and fibroblast growth factor application; a sequential allocation, three‐armed trial

Abstract

ObjectiveThe goal of this study was to evaluate the effects of perforation edge approximation and direct application of basic fibroblast growth factor (bFGF) each alone on the healing of large traumatic tympanic membrane perforations with inverted edges in humans.Study DesignProspective, sequential allocation, three-armed, controlled clinical study.SettingUniversity-affiliated teaching hospital.ParticipantsFifty-eight patients with large traumatic tympanic membrane perforations (i.e. affecting >50% of the surface area) with inverted edges were recruited. They were sequentially allocated to three groups: no intervention (n & 18), edge approximation alone (n & 20) and direct application of bFGF (n & 20). Otoscopy were performed before the treatment and at follow-up visits.Main outcome measuresThe closure rate, closure time and rate of otorrhoea.ResultsApplication of bFGF yielded a significantly higher average rate of perforation closure (100%) than edge approximation (60%) and no intervention (56%) (P < 0.05). It also significantly shortened the average closure time (12.4 ± 3.6 days) as compared to edge approximation (46.3 ± 8.7 days) and no intervention control (48.2 ± 5.3 days) (P < 0.05). Purulent otorrhoea was observed in none of the three groups.ConclusionEdge approximation of inverted edges has little benefit in improving the healing outcome of large traumatic tympanic membrane perforations and thus is not an ideal treatment option for large traumatic tympanic membrane perforations. Application of bFGF materially improves the closure rate of large traumatic tympanic membrane perforations and significantly shortens the closure time.

A pilot study investigating basic fibroblast growth factor for the repair of chronic tympanic membrane perforations in pediatric patients

“…The 83% success rate demonstrated in this study is comparable with published conventional myringoplasty series [3], but is lower than that demonstrated by other authors utilizing bFGF [8,9,16]. One Table 2 Operating theatre cost analysis between conventional underlay myringoplasty procedure and trial FGF procedure (all figures in Australian dollars).…”

“…In Hakuba's study [13] cholesteatoma was first identified up to 17 months post-treatment suggesting that long-term follow-up is indicated for patients undergoing this technique. Lou and Wang [8] reported the development of myringitis in 52% of cases in whom gelatin sponge was utilized, however CT imaging confirmed the absence of any middle ear or mastoid inflammation in these cases and the myringitis did not have any effect on hearing outcome or patient symptoms. None of our patients treated with bFGF and gelfoam developed the myringitis described by Lou and Wang.…”

“…The application of bFGF has been shown to significantly increase the overall closure rate of TMPs and reduce the average closure time [7,8]. The bFGF regeneration technique has been reported to be safe [9,10], simple and cost-effective, with benefits over conventional surgical treatment [9,11] and high rates of success.…”

“…Some authors have included older children (>13 years) [8,13], there is one study that included younger children. Zhang [8] included patients as young as 3 years of age in his study however no distinction was made between children and adults in the analysis and the published results do not allow a comparison to be made. Tympanic membrane perforation Otitis media Myringoplasty Fibroblast growth factor Regeneration Pediatric…”

In Response to the Letter to the Editor Regarding: Heparin Binding–Epidermal Growth Factor-Like Growth Factor for the Regeneration of Chronic Tympanic Membrane Perforations in Mice

“…Using off label growth factors, without demonstrating safety and nonototoxicity in nonhuman models, in patient populations with wounds that likely would have healed without treatment and without long-term follow-up should be considered ''risky.'' [20][21][22][23][24][25] …”