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Comparision between composite cartilage grafts and temporalis fascia graft in tympanoplasty

Study evaluating the effectiveness of composite cartilage grafts vs temporalis fascia graft in tympanoplasty - Randomised controlled trial - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078276
Enrollment
60
Registered
2024-12-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H661- Chronic tubotympanic suppurative otitis media

Interventions

Intervention1: Composite cartilage graft: Composite cartilage graft will be used during surgery and kept until graft acceptance and observed till 12 weeks post op Control Intervention1: Temporalis fas

Sponsors

Arupadai Veedu Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All cases of Tubotympanic type of CSOM with perforation of the tympanic membrane with dry ear Includes patient in the age group of 18â??60 years

Exclusion criteria

Exclusion criteria: 1) All cases of Attico antral type of CSOM. 2) Patients with craniofacial abnormalities (cleft palate). 3) Otogenic intra cranial complications in the past. 4) External ear infective conditions. 5) Pre operative ossicular discontinuity, fixed foot plate. 6) Patients with evidence of focal sepsis.

Design outcomes

Primary

MeasureTime frame
Tympanic membrane closure success rate assessed by otoscopy and audiometry at specified follow-up intervalsTimepoint: 3weeks, 6 weeks & 12 weeks

Secondary

MeasureTime frame
Improvement in pure tone audiometry (PTA) thresholds, postoperative complications (e.g., graft displacement, infection), and patient-reported outcomes (e.g., subjective hearing improvement, satisfaction with surgery).Timepoint: 3weeks, 6 weeks & 12 weeks

Countries

India

Contacts

Public ContactAtul Bage

Aarupadai Veedu Medical College and Hospital

otorhinolaryngology@avmc.edu.in7745040514

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026