Clinical Research Directory

Comparison of Results of Myringoplasty Using Biodesign - an Otologic Graft Made From Porcine Small Intestinal Submucosa, Temporalis Fascia, or Tragal Perichondrium - a Retrospective Cohort Analysis

The goal of this observational, retrospective study is to learn whether a ready-made graft patch (Biodesign, made from porcine small intestinal submucosa) works as well as a participant's own tissue graft (such as tragal perichondrium or temporalis fascia) to close a hole in the eardrum (tympanic membrane perforation). The main questions this study aims to answer are: Does the eardrum hole close after surgery, and is the closure rate similar between Biodesign and autologous tissue grafts? Do participants have similar hearing improvement after surgery (measured by the air-bone gap, a common hearing test measure)? Is the operating time different between the graft types? Are there differences in complications or adverse reactions? Study hypothesis: Biodesign will have a similar eardrum closure rate compared with autologous tissue grafts, with similar hearing improvement and low complication rates, and may be associated with a shorter operating time. How the study will work: Investigators will review medical records of participants who had myringoplasty/tympanoplasty for eardrum perforation in the department between 2020 and 2024. Data already recorded as part of usual care will be collected, including: pre-surgery eardrum findings (size and location of the perforation) and hearing tests; operative details (technique and operating time); and follow-up at about 3 months, including an ear exam to confirm closure and check for adverse reactions, plus a hearing test. Participants will be excluded if they have other ear conditions (such as cholesteatoma, otosclerosis, or tympanosclerosis), if the eardrum was described as flaccid, or if follow-up or post-operative hearing data are missing.