A Prospective Comparative Study of Dry vs Wet Temporalis Fascia Graft in Tympanoplasty (NCT07595484) | Clinical Trial Compass
CompletedNot Applicable
A Prospective Comparative Study of Dry vs Wet Temporalis Fascia Graft in Tympanoplasty
Pakistan92 participantsStarted 2025-09-10
Plain-language summary
This study was conducted to compare two methods of using temporalis fascia graft in tympanoplasty, namely wet temporalis fascia graft and dry temporalis fascia graft. Tympanoplasty is an ear surgery performed to repair a hole in the ear drum and to improve hearing in patients with chronic otitis media. Temporalis fascia is a thin layer of tissue taken from the area over the temple muscle and is commonly used as graft material for repair of the ear drum.
The study included adult patients aged 18 to 60 years who had chronic otitis media with inactive mucosal disease, a large central perforation of the ear drum, and conductive hearing loss confirmed on pure-tone audiometry. Patients were assigned to one of two treatment groups. One group underwent tympanoplasty using a wet temporalis fascia graft, while the other group underwent tympanoplasty using a dry temporalis fascia graft.
The main purpose of the study was to assess whether one graft preparation technique gave better surgical and hearing outcomes than the other. The outcomes were assessed three months after surgery. Hearing improvement was measured by comparing the air-bone gap before and after surgery on pure-tone audiometry. Graft success was assessed by otoscopic examination to determine whether the graft had healed properly, remained in correct position, and closed the ear drum perforation. Complete air-bone gap closure was also assessed as an additional hearing outcome.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 18 to 60 years.
* Patients of either gender.
* Patients diagnosed with chronic otitis media.
* Patients with inactive mucosal disease, with no active ear discharge.
* Patients with a large central perforation of the tympanic membrane.
* Tympanic membrane perforation persisting for at least 6 weeks.
* Patients with pure conductive hearing loss confirmed on pure-tone audiometry.
Exclusion Criteria:
* Patients with active otitis media, acute infection, or active ear discharge.
* Patients with tympanosclerosis or ossicular necrosis affecting ossicular chain mobility.
* Patients with a history of previous ear surgery that could affect tympanoplasty outcomes, such as ossiculoplasty or mastoidectomy, except prior myringotomy.
* Patients with sensorineural hearing loss or mixed hearing loss.
* Patients with conditions impairing wound healing or postoperative care compliance, including uncontrolled diabetes mellitus or immunodeficiency disorders.
* Patients with confirmed Eustachian tube dysfunction.
* Patients with active infection in the throat, nose, paranasal sinuses, or oral cavity.
* Patients with bleeding disorders.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.