Negative Outcome of Temporalis Fascia Graft in Tympanoplasty with Excessive Bleeding: A Retrospective Study.

ABSTRACT

Background and Objectives: Non-autologous graft materials hold promise for tympanic membrane (TM) perforation closure. In the present manuscript, we aimed to evaluate the influence of clinical and surgical (i.e., graft materials) characteristics on tympanoplasty outcome in chronic otitis media (COM). Materials and Methods: We retrospectively reviewed clinical and surgical characteristics of COM patients with TM perforation treated with tympanoplasty and mastoidectomy. Univariate and multivariate appropriate tests were applied. Results: We used xenograft (porcine submucosal collagen) in 163 patients, and temporalis fascia in 210. The mean follow-up time was 37.2 months. Postoperative TM perforation (i.e., negative outcome) was detected in 11.6% of cases with xenograft, and in 12.8% with temporalis fascia. Performing uni- and multivariate analysis, we determined that large (three or all quadrants) TM perforation (p = 0.04) and moderate-to-severe intraoperative bleeding (p = 0.03) were independent prognostic factors of negative outcome. Considering the 197 patients with moderate-to-severe intraoperative bleeding, we disclosed that the use of temporalis fascia (p = 0.03) was an independent risk factor of postoperative TM perforation. Conclusions: According to our results, large TM perforation and moderate-to-severe intraoperative bleeding were independent prognostic factors of negative outcome in adult COM patients treated with tympanoplasty. In the sub-group of COM patients with excessive intraoperative bleeding, use of temporalis fascia was associated with negative outcome; these patients could benefit from xenograft materials. These findings should be tested in large randomized clinical trials.