title: Preoperative factors affecting tympanic membrane regeneration therapy using an atelocollagen and basic fibroblast growth factor.
abstract: OBJECTIVE
  The use of growth factors to achieve closure of perforated tympanic membranes (TMs) has recently become popular. However, preoperative factors affecting treatment outcomes have seldom been discussed.
  
  
  OBJECTIVE
  To evaluate preoperative factors contributing to the success or failure of healing of perforated TMs.
  
  
  METHODS
  Retrospective cohort study of 153 patients (48 males and 105 females) in whom the duration of perforation was longer than 6 months prior to treatment and who were observed for at least 1 year after treatment between July 2009 and June 2012. Eight factors considered likely to affect the outcome of perforation closure were statistically evaluated using multivariate logistic regression analysis.
  
  
  METHODS
  Each perforated TM was filled with a synthetic graft material (atelocollagen sponge and silicone membrane) containing human basic fibroblast growth factor to promote wound healing after TM perforation closure.
  
  
  METHODS
  Complete closure vs residual perforation.
  
  
  RESULTS
  After 1 year of follow-up, 101 patients (66.0%) achieved complete closure, 30 patients (19.6%) had residual pinhole perforations (<1 mm diameter), and 22 patients (14.4%) had larger residual perforations. Multivariate logistic regression analysis adjusted for each explanatory variable identified a TM without calcification (odds ratio [OR], 2.68 [95% CI, 1.17-6.15]; P = .03) and a perforation not involving the tympanic annulus (odds ratio, 2.75 [95% CI, 1.09-6.94]; P = .04) as significant. Insignificant factors included perforation margin identified on microscopy (OR, 0.24 [95% CI, 0.99-6.27]; P < .001), perforation margin without epithelial migration (OR, 7.27 [95% CI, 0.66-80.49]; P = .11), absence of preoperative otorrhea (P = .38), no previous ear operations (P = .82), perforation size (P = .14), and patient age (P = .26).
  
  
  CONCLUSIONS
  Tympanic membrane regeneration therapy can be applied to all patients, except those with cholesteatoma or malignant neoplasm. However, patients with severe calcification of the TM and those with marginal perforations close to the fibrous annulus should be treated more prudently to achieve perforation closure.
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Ehime University School of Medicine, Ehime, Japan.
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Hakuba
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Ehime University School of Medicine, Ehime, Japan.
authors.forename: Naohito
authors.initials: N
authors.lastname: Hato
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Ehime University School of Medicine, Ehime, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Okada
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Ehime University School of Medicine, Ehime, Japan.
authors.forename: Kazuyo
authors.initials: K
authors.lastname: Mise
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Ehime University School of Medicine, Ehime, Japan.
authors.forename: Kiyofumi
authors.initials: K
authors.lastname: Gyo
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003094:Collagen / Q000627:therapeutic use*; D005260:Female; D005346:Fibroblast Growth Factors / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D057234:Preoperative Period; D012038:Regeneration; D016896:Treatment Outcome; D014432:Tympanic Membrane / Q000502:physiology*; D018058:Tympanic Membrane Perforation / Q000628:therapy*
chemical_list: C059821:atelocollagen; D005346:Fibroblast Growth Factors; D003094:Collagen