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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hafiz Adil Ikram | Shaikh Zayed Hospital, Lahore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaikh Zayed Medical college/hospital, Lahore | Lahore | Punjab Province | 54000 | Pakistan |
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| ID | Term |
|---|---|
| D018058 | Tympanic Membrane Perforation |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014947 | Wounds and Injuries |
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| 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. |
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