| CTRI Number |
CTRI/2024/04/065658 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Platelet Rich Fibrin sheet in repair of ear drum |
|
Scientific Title of Study
|
Comparison of outcomes of myringoplasty using Temporalis fascia alone and Temporalis fascia with Platelet Rich Fibrin sheet - an Academic 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 |
Lalam Rama Varaha Rohini |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room no 311, ENT OPD, OPD block
Department of ENT
AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9908225826 |
| Fax |
|
| Email |
lalamrohini62@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satvinder Singh Bakshi |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
ENT OPD,
Department of ENT
AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9698420998 |
| Fax |
|
| Email |
bakshi.s@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Lalam Rama Varaha Rohini |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room no 311, ENT OPD,
Department of ENT
AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9908225826 |
| Fax |
|
| Email |
lalamrohini62@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ENT
AIIMS MANGALAGIRI,
MANGALAGIRI,GUNTUR DISTRICT,ANDHRA PRADESH , INDIA PINCODE-522503 |
|
|
Primary Sponsor
|
| Name |
Dept of ENT AIIMS Mangalagiri |
| Address |
Room no 311
Department of ENT
AIIMS MANGALAGIRI
Mangalagiri- 522503
Andhra Pradesh |
| Type of Sponsor |
Government medical college |
|
|
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 |
| LALAM RAMA VARAHA ROHINI |
AIIMS MANGALAGIRI |
room no-311
3rd floor
ENT OPD
DEPARTMENT OF ENT
Guntur
ANDHRA PRADESH |
9908225826
lalamrohini62@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Mangalagiri IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
myringoplasty by post aural approach- Standard Treatment Care |
Control Patients will under got standard treatment care that myringoplasty by post aural approach, using the underlay technique and temporalis fascia graft. follow up will be done upto 3 months. |
| Intervention |
Platelet Rich Fibrin Sheet for myringoplasty |
Patients in intervention group while undergoing myringoplasty by post aural approach, using the underlay technique and temporalis fascia graft. After placing the graft and repositioning the tympanomeatal flap,
the platelet-rich fibrin sheet will be placed over the sealed perforation single time and follow up will be done upto 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of chronic otitis media with inactive mucosal type.
2.Patients with conductive hearing loss less than 40 db.
3.Age group between 18-60 Years.
4.Patients With inactive ear for atleast 6 weeks |
|
| ExclusionCriteria |
| Details |
1.Patients with sensorineural hearing loss.
2.Pregnancy.
3.Patients with bleeding diathesis.
4.Patients with ossicular chain abnormalities.
5.Patients with mastoiditis, cholesteatoma and granulation tissue in middle ear.
6. Patients who refuses consent for PRF.
7.Patients with comorbidities like uncontrolled diabetes, hypertension, nasal allergies and COPD.
8.Patients with previous middle ear surgery, nasopharyngeal or skull base pathologies.
9. Patients coming for revision surgery.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| graft uptake |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in hearing threshold |
3 months |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
Final Enrollment numbers achieved (Total)= "128"
Final Enrollment numbers achieved (India)="128" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Myringoplasty is defined as surgical closure of tympanic membrane perforation, without reconstruction of ossicular chain. It is used in the treatment of chronic otitis media. Chronic suppurative otitis media (CSOM) is a long-standing infection of a part or whole of the middle ear cleft characterized by ear discharge and a permanent perforation. It is also the single most important cause of hearing impairment in rural population. Platelet-rich fibrin (PRF) is an autogenous material that is derived from a person’s own platelets and is used to enhance wound healing and tissue regeneration. PRF is proposed to have a direct effect on enhancing a patient’s wound healing by suprasaturating the wound with growth factors that promote tissue healing. Clinically, PRF is easily produced bedside from the patient’s own blood. Platelet rich fibrin is composed of an assembly of a cytokines, glycaemic chains, and structural glycoproteins enmeshed within a slowly polymerised fibrin network. These biochemical components help in healing through synergistic mechanisms. PRF hastens the cell proliferation and also offers inflammatory protection to grafts. As PRF membrane has a strong, elastic fibrin structure containing growth factors, it may improve graft uptake and healing. Data regarding effect of PRF sheet in repair of chronic tympanic membrane perforations is limited and therefore the present study is being conducted to evaluate graft uptake and hearing improvement with the usage of PRF sheet in repair of chronic tympanic membrane perforation along with temporalis fascia and comparing the outcomes with conventional myringoplasty. |