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A randomised controlled trial comparing spontaneous healing, gelfoam patching and edge-approximation plus gelfoam patching in traumatic tympanic membrane perforation with inverted or everted edges.

AbstractOBJECTIVE:
To compare the outcome of patients with dry traumatic tympanic membrane perforation after spontaneous healing and gelfoam patching with or without perforation edge approximation.
DESIGN:
Prospective clinical study.
SETTING:
University-affiliated teaching hospital.
PARTICIPANTS:
Ninety-one patients with acute dry traumatic tympanic membrane perforation inverted or everted edges were recruited. They were randomly allocated to three groups: spontaneous healing (n=31), gelfoam patching (n=30) and edge-approximation plus gelfoam patching (n=30). Otoscopy and tympanometry were performed before the treatment and at follow-up visits.
MAIN OUTCOME MEASURES:
  Healing rate, healing time, ear infection rate and morphological changes during healing process.
RESULTS:
The overall healing rate was 85% in the spontaneous healing group, lower than that in the two gelfoam patching groups (97%), but the difference failed to reach a statistical significance (P>0.05). The average healing time was 30 ± 10.1 days in the spontaneous healing group, significantly longer (P<0.01) than that in the other two groups (16 ± 5.6 and 18 ± 4.7 days, respectively). Middle ear infection rate did not differ significantly (7%, 3% and 3%, respectively). Spontaneous healing resulted in formation of scabs at the perforation edges, which was effectively prevented by gelfoam patching.
CONCLUSIONS:
Gelfoam patching may facilitate healing of traumatically perforated tympanic membrane. Approximation of folded perforation edges is not necessary in gelfoam patching.
AuthorsZ-C Lou, J-G He
JournalClinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery (Clin Otolaryngol) Vol. 36 Issue 3 Pg. 221-6 (Jun 2011) ISSN: 1749-4486 [Electronic] England
PMID21518294 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Copyright© 2011 Blackwell Publishing Ltd.
Chemical References
  • Hemostatics
Topics
  • Adult
  • Female
  • Follow-Up Studies
  • Gelatin Sponge, Absorbable (therapeutic use)
  • Head Injuries, Closed (complications)
  • Hemostatics (therapeutic use)
  • Humans
  • Male
  • Middle Aged
  • Otoscopy
  • Prospective Studies
  • Treatment Outcome
  • Tympanic Membrane (injuries, pathology, surgery)
  • Tympanic Membrane Perforation (diagnosis, etiology, surgery)
  • Tympanoplasty (methods)
  • Wound Healing

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