Biosynthetic graft versus autologous graft tympanoplasty: a prospective randomized controlled trial.

Autor: Lee HSH; Department of Otorhinolaryngology, Head and Neck Surgery, Kowloon West Cluster, Hong Kong, China. herbertshlee@gmail.com., Kwok HHC; Department of Otorhinolaryngology, Head and Neck Surgery, Kowloon West Cluster, Hong Kong, China., Xiao MLQ; Clinical Research Centre, Kowloon West Cluster, Hong Kong, China., Wai CKC; Department of Otorhinolaryngology, Head and Neck Surgery, Kowloon West Cluster, Hong Kong, China.
Jazyk: angličtina
Zdroj: European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery [Eur Arch Otorhinolaryngol] 2024 Dec 19. Date of Electronic Publication: 2024 Dec 19.
DOI: 10.1007/s00405-024-09166-y
Abstrakt: Purpose: The aim of this study was to compare the graft success rate, hearing outcome, and operative time in patients undergoing tympanoplasty for tympanic membrane perforation with the use of either biosynthetic or autologous graft material.
Methods: This was a prospective randomized controlled trial performed at a regional hospital. 41 patients were enrolled and randomized, with 20 patients allocated to the treatment arm (biosynthetic graft) and 21 patients allocated to the control arm (autologous graft). The primary outcome was graft success rate. The secondary outcomes were operative time and hearing outcomes (assessed by pure tone audiogram hearing threshold improvement and closure of air-bone gap at 6 months postoperatively).
Results: There was no statistically significant difference in the graft success rate between the two groups (P = 0.645). There was also no statistically significant difference in the hearing outcomes (hearing thresholds improvement P = 0.886, air-bone gap improvement P = 0.651). However operative time was significantly shorter in the biosynthetic graft group compared with the autologous graft group (45.5 min vs. 72 min respectively; P < 0.001).
Conclusion: This study demonstrates that tympanoplasty using a biosynthetic graft material can achieve comparable graft success rate and hearing outcomes as compared with conventional autologous graft tympanoplasty, but with the added benefits of a shortened operative time and avoiding incisions.
Competing Interests: Declarations. Ethical approval: The study was approved by the Kowloon West Cluster Ethics Committee (Ref.: KW/FR-21-119(162-04)). Consent to participate and consent to publish: Informed consent was obtained from all individual participants included in the study. The participants have consented to the submission of this transcript to the journal. Competing interests: The authors have no relevant financial or non-financial interests to disclose. The authors have no conflicts of interest to declare that are relevant to the content of this article. All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest or non-financial interest in the subject matter or materials discussed in this manuscript. The authors have no financial or proprietary interests in any material discussed in this article.
(© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
Databáze: MEDLINE
Externí odkaz: