Comparing Chitosan-dextran Gel and Gelfoam in Middle Ear Surgery to Repair Eardrum Perforations and Related Conditions

What this Trial Is About

This research aims to compare the use of Chitosan-dextran Chitodex gel with the current standard treatment, Gelfoam, as packing materials for the middle ear and external auditory canal during tympanoplasty, ossiculoplasty, and mastoidectomy surgeries. It focuses on patients with tympanic membrane perforations, ossicular chain damage, or chronic otitis media and seeks to identify which material better supports healing and reduces inflammation. The study is a single-blinded, randomized trial assessing surgical success and healing outcomes. During surgery, Chitodex gel is applied in a similar manner to Gelfoam. Approximately 2 mL of gel or foam is placed inside the middle ear to support the graft, followed by about 3 mL applied to the external auditory canal as packing. Both materials come in sterile packaging, and surgeons administer the product during the procedure. The study measures the effectiveness of each product in sealing the graft and preventing air leakage, with images and notes taken for evaluation. Participants will be monitored at several points after surgery 2 and 6 weeks, then 3 and 6 months post-operation. Researchers will check tympanic membrane closure using otoscopic or microscope examination. Additional assessments include hearing improvement, eardrum function, quality of life, surgical ease, operation duration, and the clearance of Chitodex gel from the ear. These evaluations will help determine which packing agent is preferable for middle ear surgery.

Effect of Chitodex Gel in Tympanoplasty Surgery