OBJECTIVE: To test the efficacy and safety of a hyaluronan-based biomembrane in stimulating the healing process in patients undergoing tympanomastoid surgery. STUDY DESIGN: The trial was an open, two-arm, controlled, randomized, prospective, multicenter study conducted at two different hospitals. PATIENTS: Sixty subjects (18-65 years of age, both sexes) with chronic cholesteatomatous otitis media were enrolled and treated by the "one-stage open technique." Efficacy and safety parameters were assessed at 3, 5, 7, 9, 11, 13, 17, 21, and 25 weeks after surgery. Three sets of composite criteria were considered: patient's assessment of quality of healing, otomicroscopy, and audiometry. RESULTS: Of the 60 patients, 50 completed the study. Subjects treated with the biomembrane had statistically significant better scores than controls (no treatment) for all variables considered, excluding audiometry (no significant differences). No adverse events occurred in treated patients. CONCLUSION: Data demonstrate that the application of a hyaluronan-based biomembrane improves the healing of the mastoid cavity following "open" tympanoplasty. In particular, re-epithelialization was significantly faster after the application of the biomembrane. Moreover, the device neither caused any adverse events nor showed signs of ototoxicity. Re-epithelialization of open cavities and tympanic grafts still represents for surgeons an unpredictable step in the healing process. Hyaluronian-derivates may effectively contribute to the reduction of such variability.
RCT Entities:
OBJECTIVE: To test the efficacy and safety of a hyaluronan-based biomembrane in stimulating the healing process in patients undergoing tympanomastoid surgery. STUDY DESIGN: The trial was an open, two-arm, controlled, randomized, prospective, multicenter study conducted at two different hospitals. PATIENTS: Sixty subjects (18-65 years of age, both sexes) with chronic cholesteatomatous otitis media were enrolled and treated by the "one-stage open technique." Efficacy and safety parameters were assessed at 3, 5, 7, 9, 11, 13, 17, 21, and 25 weeks after surgery. Three sets of composite criteria were considered: patient's assessment of quality of healing, otomicroscopy, and audiometry. RESULTS: Of the 60 patients, 50 completed the study. Subjects treated with the biomembrane had statistically significant better scores than controls (no treatment) for all variables considered, excluding audiometry (no significant differences). No adverse events occurred in treated patients. CONCLUSION: Data demonstrate that the application of a hyaluronan-based biomembrane improves the healing of the mastoid cavity following "open" tympanoplasty. In particular, re-epithelialization was significantly faster after the application of the biomembrane. Moreover, the device neither caused any adverse events nor showed signs of ototoxicity. Re-epithelialization of open cavities and tympanic grafts still represents for surgeons an unpredictable step in the healing process. Hyaluronian-derivates may effectively contribute to the reduction of such variability.
Authors: Marco Berlucchi; Paolo Castelnuovo; Andrea Vincenzi; Bruno Morra; Ernesto Pasquini Journal: Eur Arch Otorhinolaryngol Date: 2008-10-23 Impact factor: 2.503