Trial reportEuropean 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 Surgery2025
Biosynthetic graft versus autologous graft tympanoplasty: a prospective randomized controlled trial.
Trial report in 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, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe 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.
methodsThis 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).
resultsThere 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).
conclusionThis 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.
Indexed as
Identifiers
39702806What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.