| CTRI Number |
CTRI/2024/06/068565 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of platelet rich fibrin (a blood product - derived from patients own blood) on complete repair of perforation in eardrum (tympanic membrane) on using along with surgery (type 1 Tympanoplasty). |
|
Scientific Title of Study
|
Efficacy of Autologous Platelet Rich Fibrin (PRF) on successful closure rate in Type 1 Tympanoplasty : Open label randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mehul Barfa |
| Designation |
junior resident |
| Affiliation |
AIIMS , Raipur |
| Address |
Department of ENT and Head and neck surgery , AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8225063873 |
| Fax |
|
| Email |
mehulbarfa0131999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharmistha Chakravarty |
| Designation |
Associate Professor |
| Affiliation |
AIIMS , Raipur |
| Address |
Department of ENT and Head & Neck Surgery, AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9163505756 |
| Fax |
|
| Email |
sharmisthachakravarty@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mehul Barfa |
| Designation |
Junior Resident |
| Affiliation |
AIIMS , Raipur |
| Address |
Department of Otolaryngology & Head and Neck Surgery, AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8225063873 |
| Fax |
|
| Email |
mehulbarfa0131999@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Raipur Tatibandh, Raipur, State - Chhattisgarh , 492099 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Mehul Barfa |
All India Institute of medical sciences, Raipur |
Room no 11 , Department of ENT and Head and Neck , AIIMS Raipur
Raipur
CHHATTISGARH |
8225063873
mehulbarfa0131999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS , Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H720||Central perforation of tympanic membrane, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Platelet rich fibrin (PRF) in Type 1 tympanoplasty |
Temporalis fascia placed beneath TM flap platelet rich Fibrin (PRF) membrane will be , placed over the tympanomeatal flap layer
then gel foam will be placed in EAC
Total duration required will be
2 hours |
| Comparator Agent |
Type 1 Tympanoplasty |
Temporalis fascia placed beneath TM flap gel foam will be placed in EAC, total duration will be 1.5 hr. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age from 18 to 65 , inactive chronic otitis media mucosal type, hearing less than 50 db, unilateral case of chronic suppurative otitis media , Dry from last 4 weeks |
|
| ExclusionCriteria |
| Details |
Chronic otitis media squamous , Hearing loss more than 50 db , patient with active discharge , revision tympanoplasty , any co-morbidities like DM . |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the successful closure rate (complete graft uptake and healing of perforation) in experimental group (Type 1 tympanoplasty with Platelet rich fibrin) and control group (Type 1 tympanoplasty without Platelet rich fibrin). |
Follow up the patients at 1,3and 6 months post intervention and observe for Graft uptake – Full closure/ Residual perforation. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To assess healing time in repair of perforation
To assess hearing outcome in term of A-B gap closure |
1,3and 6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| Date of Study Completion (India) |
28/08/2025 |
| Date of First Enrollment (Global) |
20/06/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Thesis Protocol Summary Title - “ Efficacy of Autologous Platelet Rich Fibrin (PRF) on successful closure rate in Type 1 Tympanoplasty : Open label randomized controlled trial †- Dr Mehul Barfa Objectives – Primary: 1. To study the successful closure rate (complete graft uptake and healing of perforation) in experimental group (Type 1 tympanoplasty with PRF) and control group (Type 1 tympanoplasty without PRF). 2.Secondary: 1) To assess the healing time for repair of perforation in experimental group (Type 1 tympanoplasty with PRF) and control group (Type 1 tympanoplasty without PRF). 2. To assess hearing outcome in terms of A-B gap closure in the experimental and control groups after six months of surgery Justification - Use of PRF on the temporalis fascia as a graft material can have better dimensional stability, especially in large perforations. As it is a thin membrane, it does not impede sound conducting mechanism and subsequently leads to better outcome, particularly with respect to achieving an intact TM and hearing improvement . Study design - A randomized control trial , active control, open label study. Randomization - Systematic randomization using computer-based software. STUDY DURATION: 18 MONTHS Sample size – Total study population – 50 Case – 25 , control – 25 Methodology – COM cases – inactive In cases - Temporalis fascia placed beneath TM flap , platelet rich Fibrin (PRF) membrane will be placed over the tympanomeatal flap layer then gelfoam will be placed in EAC , In control - Temporalis fascia placed beneath TM flap , gel foam will be placed in EAC. Patients will be followed up at 7 days , 1, 3 and 6 months and observe for Graft uptake – Full closure/ Residual perforation otoendoscopically , and note the time of healing. And PTA will be performed at 3 and 6 months of surgery. Autologus PRF preparations will be done from patients blood 30 ml of whole blood ,after process of centrifugation middle layer of PRF will be extracted and will be used for study . All the data will be collected in excel sheet and |