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

NCT07595484 | Completed

• 1 other identifier: ShaikhZayedH2
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Otitis Media; Tympanic Membrane Perforation

Keywords

Tympanoplasty; Temporalis fascia graft; Wet temporalis fascia graft; Dry temporalis fascia graft; Tympanic membrane perforation; Large central perforation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Complete Air-Bone Gap Closure

  3 months after surgery

Study Arms (2)

Group Wet Temporalis Fascia Graft

EXPERIMENTAL

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

Group Dry Temporalis Fascia Graft

ACTIVE COMPARATOR

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

Interventions

Wet Temporalis Fascia Graft Tympanoplasty PROCEDURE

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

Group Wet Temporalis Fascia Graft

Dry Temporalis Fascia Graft Tympanoplasty PROCEDURE

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.

Group Dry Temporalis Fascia Graft

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaikh Zayed Hospital, Lahore: lead

Study Sites (1)

Shaikh Zayed Medical college/hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Study Officials

• Hafiz Adil Ikram

  Shaikh Zayed Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start: September 10, 2025
• Primary Completion: March 10, 2026
• Study Completion: March 10, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

PA (1)