Abstract | OBJECTIVE: STUDY DESIGN: Randomized control trial. SETTING: General hospital. PATIENTS AND METHODS: A total of 63 chronic TMPs were randomly selected from outpatients. INTERVENTION: Of the total 63 chronic TMPs, 53 were randomly assigned to the basic fibroblast growth factor (b-FGF) group and the remaining 10 were randomly assigned to the control group. Materials used for the TM repair were gelatin sponge and fibrin glue with/without b-FGF. After creating a mechanical disruption of the edge of the TMP, a gelatin sponge was immersed in b-FGF or saline (for the control group) and placed over the perforation. Fibrin glue was dripped over the sponge as a sealant. MAIN OUTCOME MEASURES: The effectiveness of this therapy was evaluated by closure rates, hearing level, and sequelae 3 weeks after treatment. The treatment was repeated up to 4 times for cases in which complete closure of the TMP was not achieved after 1 round of treatment. RESULTS: Complete closure of the TMP was achieved in more than 98.1% (52/53) of the patients in the b-FGF group and 10% (1/10) of the patients in the control group. The average hearing level of all patients with successful TM repair was improved. Serious sequelae were not observed in any patient. CONCLUSION: This study demonstrates that a combination of gelatin sponge, b-FGF, and fibrin glue enables the regeneration of the TM without conventional operative procedures. This innovative regenerative therapy is an easy, safe, cost-effective, and minimally invasive outpatient treatment.
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Authors | Shin-Ichi Kanemaru, Hiroo Umeda, Yoshiharu Kitani, Tatsuo Nakamura, Shigeru Hirano, Juichi Ito |
Journal | Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology
(Otol Neurotol)
Vol. 32
Issue 8
Pg. 1218-23
(Oct 2011)
ISSN: 1537-4505 [Electronic] United States |
PMID | 21897328
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Fibrin Tissue Adhesive
- Fibroblast Growth Factor 2
- Gelatin
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Child
- Female
- Fibrin Tissue Adhesive
(therapeutic use)
- Fibroblast Growth Factor 2
(therapeutic use)
- Gelatin
(therapeutic use)
- Hearing Loss
(etiology, therapy)
- Humans
- Male
- Middle Aged
- Regeneration
(physiology)
- Tissue Engineering
(methods)
- Treatment Outcome
- Tympanic Membrane
(physiology)
- Tympanic Membrane Perforation
(complications, therapy)
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