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NCT Number: NCT07595484

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.

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Key information

Conditions

Chronic Otitis Media Ear Diseases Otorhinolaryngologic Diseases Tympanic Membrane Perforation Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaikh Zayed Medical college/hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Mean hearing gain after tympanoplasty

    Time frame: 3 months after surgery

    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.

  2. Graft uptake rate after tympanoplasty

    Time frame: 3 months after surgery

    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.

Secondary outcomes

  1. Complete Air-Bone Gap Closure

    Time frame: 3 months after surgery

    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.

Sponsors and collaborators

Lead sponsor

Shaikh Zayed Hospital, Lahore

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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