A Prospective Comparative Study of Dry vs Wet Temporalis Fascia Graft in Tympanoplasty

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.

Study Overview

• Status: Completed
• Conditions: Tympanic Membrane Perforation; Chronic Otitis Media
• Intervention / Treatment: Procedure: Wet Temporalis Fascia Graft Tympanoplasty; Procedure: Dry Temporalis Fascia Graft Tympanoplasty

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Shaikh Zayed Medical college/hospital, Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Wet Temporalis Fascia Graft; Participants in this group underwent tympanoplasty using the wet temporalis fascia graft technique for repair of tympanic membrane perforation.	Procedure: Wet Temporalis Fascia Graft Tympanoplasty; Tympanoplasty was performed using a wet temporalis fascia graft to repair the tympanic membrane perforation. Postoperative assessment was performed at 3 months using otoscopic examination and pure-tone audiometry
Active Comparator: Group Dry Temporalis Fascia Graft; Participants in this group underwent tympanoplasty using the dry temporalis fascia graft technique for repair of tympanic membrane perforation.	Procedure: Dry Temporalis Fascia Graft Tympanoplasty; Tympanoplasty was performed using a dry temporalis fascia graft to repair the tympanic membrane perforation. Postoperative assessment was performed at 3 months using otoscopic examination and pure-tone audiometry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean hearing gain after tympanoplasty	Mean hearing gain was measured by comparing the preoperative and postoperative air-bone gap on pure-tone audiometry. The air-bone gap was assessed at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz. Mean hearing gain was calculated by subtracting the postoperative air-bone gap from the preoperative air-bone gap. A greater reduction in air-bone gap indicated better hearing improvement after tympanoplasty.	3 months after surgery
Graft uptake rate after tympanoplasty	Graft uptake rate was assessed by otoscopic examination. A successful graft uptake was defined as an intact and correctly positioned graft with closure of the tympanic membrane perforation, without evidence of graft rejection or active infection.	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Air-Bone Gap Closure	Complete air-bone gap closure was defined as a postoperative air-bone gap of 10 dB or less on pure-tone audiometry. This outcome was used to assess clinically meaningful improvement in conductive hearing loss after tympanoplasty.	3 months after surgery

Collaborators and Investigators

• Sponsor: Shaikh Zayed Hospital, Lahore
• Investigators: Principal Investigator: Hafiz Adil Ikram, Shaikh Zayed Hospital, Lahore

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2025
• Primary Completion (Actual): March 10, 2026
• Study Completion (Actual): March 10, 2026

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Tympanic membrane perforation; Tympanoplasty; Temporalis fascia graft; Wet temporalis fascia graft; Dry temporalis fascia graft; Large central perforation
• Additional Relevant MeSH Terms: Wounds and Injuries; Otorhinolaryngologic Diseases; Ear Diseases; Tympanic Membrane Perforation
• Other Study ID Numbers: ShaikhZayedH2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No