title: 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: OBJECTIVE
  The 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.
  
  
  METHODS
  Prospective, sequential allocation, three-armed, controlled clinical study.
  
  
  METHODS
  University-affiliated teaching hospital.
  
  
  METHODS
  Fifty-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.
  
  
  METHODS
  The closure rate, closure time and rate of otorrhoea.
  
  
  RESULTS
  Application 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.
  
  
  CONCLUSIONS
  Edge 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.
authors.affiliation: Department of Otorhinolaryngology, Affiliated Yiwu Hospital of Wenzhou Medical College, Yiwu, China. ouzhengcai@163.com
authors.forename: Z-C
authors.initials: ZC
authors.lastname: Lou
authors.forename: Y-B-Z
authors.initials: YB
authors.lastname: Wang
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D016222:Fibroblast Growth Factor 2 / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D038781:Otoscopy; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D018058:Tympanic Membrane Perforation / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D014945:Wound Healing / Q000502:physiology*; D055815:Young Adult
chemical_list: D016222:Fibroblast Growth Factor 2