| CTRI Number |
CTRI/2024/12/078276 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision between composite cartilage grafts and temporalis fascia graft in tympanoplasty |
|
Scientific Title of Study
|
Study evaluating the effectiveness of composite cartilage grafts vs temporalis fascia graft in tympanoplasty - Randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anirudh Gaekwad |
| Designation |
Post Graduate |
| Affiliation |
AARUPADAI VEEDU MEDICAL COLLEGE |
| Address |
Opd Number 9
Department Of Otorhinolaryngology
Aarupadai Veedu Medical College And Hospital
Kirumampakkam
Pondicherry
Opd Number 9
Department Of Otorhinolaryngology
Aarupadai Veedu Medical College And Hospital
Kirumampakkam
Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
7745040514 |
| Fax |
|
| Email |
anirudhgaekwad@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Atul Bage |
| Designation |
Professor |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Opd number 9
Department of Otorhinolaryngology
Aarupadai Veedu Medical College and Hospital
Kirumampakkam
Pondicherry
607402
Opd number 9
Department of Otorhinolaryngology
Aarupadai Veedu Medical College and Hospital
Kirumampakkam
Pondicherry
607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
7745040514 |
| Fax |
|
| Email |
otorhinolaryngology@avmc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Atul Bage |
| Designation |
Professor |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Opd number 9
Department of Otorhinolaryngology
Aarupadai Veedu Medical College and Hospital
Kirumampakkam
Pondicherry
607402
Opd number 9
Department of Otorhinolaryngology
Aarupadai Veedu Medical College and Hospital
Kirumampakkam
Pondicherry
607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
7745040514 |
| Fax |
|
| Email |
otorhinolaryngology@avmc.edu.in |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu Medical College, Pondy Cuddalore Main road Kirumampakkam Bahour, Kirumampakkam, Puducherry 607402 |
|
|
Primary Sponsor
|
| Name |
Arupadai Veedu Medical College and Hospital |
| Address |
Opd number 9
Department of Otorhinolaryngology
Aarupadai Veedu Medical College and Hospital
Kirumampakkam
Pondicherry
607402 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anirudh Gaekwad |
Aarupadai Veedu Medical College and Hospital |
Opd number 9
Department of Otorhinolaryngology
Aarupadai Veedu Medical College and Hospital
Kirumampakkam
Pondicherry
607402
Pondicherry
PONDICHERRY |
7745040514
anirudhgaekwad@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aarupadai Veedu Medical college, Pondicherry Institutional Human Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Composite cartilage graft |
Composite cartilage graft will be used during surgery and kept until graft acceptance and observed till 12 weeks post op |
| Comparator Agent |
Temporalis fascia graft |
Temporalis Fasciae graft will be used in during surgery and kept until graft acceptance and observed till 12 weeks post op |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All cases of Tubotympanic type of CSOM with perforation of the tympanic membrane with dry ear
Includes patient in the age group of 18–60 years
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tympanic membrane closure success rate assessed by otoscopy and audiometry at specified follow-up intervals |
3weeks, 6 weeks & 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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). |
3weeks, 6 weeks & 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - ANYONE IN NEED OF THE DATA CAN CONTACT ME ON anirudhgaekwad@hotmail.com
- For how long will this data be available start date provided 11-06-2026 and end date provided 11-06-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Tympanoplasty,
a surgical procedure aimed at repairing the tympanic membrane (eardrum), has
been a cornerstone in the management of various middle ear pathologies,
including chronic otitis media and tympanic membrane perforations. The success
of tympanoplasty largely depends on the choice of graft material utilized for
the reconstruction of the tympanic membrane. Among the commonly employed graft
materials, temporalis fascia and composite cartilage-perichondrium grafts have
gained significant attention due to their unique properties and favourable
outcomes reported in clinical practice.
Temporalis
fascia, harvested from the temporalis muscle, has been widely utilised in
tympanoplasty for decades. Its pliability, availability, and low immunogenicity
make it a popular choice among otologic surgeons. However, concerns regarding
its long-term durability and propensity for retraction have led to the
exploration of alternative graft materials.
In
recent years, one-piece composite cartilage-perichondrium grafts have emerged
as a promising alternative to temporalis fascia. Comprising both cartilage and
perichondrium layers harvested from the tragus or conchal bowl, these grafts
offer structural support, stability, and reduced risk of retraction. Moreover,
they possess inherent vascularization, potentially promoting better graft
incorporation and long-term outcomes.
Despite
the growing body of literature comparing these graft materials, there remains a
lack of consensus regarding the optimal choice for tympanoplasty. While some
studies have demonstrated superior outcomes with composite
cartilage-perichondrium grafts, others have reported comparable success rates
between the two materials. Therefore, a comprehensive comparative analysis is
warranted to elucidate the advantages and limitations of temporalis fascia and
composite cartilage-perichondrium grafts in tympanoplasty.
This
study is a comparative analysis of types of grafts used in comparison with the
tympanic membrane perforation and post operative assessment with audiology and
otoendoscopic findings and hence conclude on graft of choice for tympanoplasty
in a coastal region. |