| CTRI Number |
CTRI/2019/02/017468 [Registered on: 05/02/2019] Trial Registered Prospectively |
| Last Modified On: |
08/02/2020 |
| 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
|
A study to compare graft uptake in surgery of tympanic membrane perforations by adding a blood product from the patients own blood to help promote healing during the surgery. |
|
Scientific Title of Study
|
A Randomised controlled trial on the efficacy of topical application of autologous Platelet Rich Plasma(PRP) on graft uptake rate in adults undergoing Type 1 Tympanoplasty for inactive COM mucosal disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakesh Datta |
| Designation |
Professor |
| Affiliation |
Armed Forces Medical College (AFMC) |
| Address |
Department of ENT
Armed Forces Medical College
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411040
India |
| Phone |
7508468671 |
| Fax |
|
| Email |
Rakeshdatta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh Datta |
| Designation |
Professor |
| Affiliation |
Armed Forces Medical College (AFMC) |
| Address |
Department of ENT
Armed Forces Medical College
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411040
India |
| Phone |
7508468671 |
| Fax |
|
| Email |
Rakeshdatta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akash |
| Designation |
Resident |
| Affiliation |
Armed Forces Medical College (AFMC) |
| Address |
Department of ENT
Armed Forces Medical College
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411040
India |
| Phone |
7798312988 |
| Fax |
|
| Email |
akashzzz559@gmail.com |
|
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Source of Monetary or Material Support
|
| Armed Forces Medical College, Pune is the source of material and infrastructural support |
|
|
Primary Sponsor
|
| Name |
Dr Rakesh Datta |
| Address |
Department of ENT
Armed Forces Medical College
Pune
MAHARASHTRA 411040 |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 Rakesh Datta |
Armed Forces Medical College |
Department of ENT
Armed Forces Medical College
Pune 411040
MAHARASHTRA
Pune
MAHARASHTRA |
07508468671
Rakeshdatta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Armed Forces Medical College |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H720||Central perforation of tympanic membrane, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Type 1 Tympanoplasty |
Standard surgery for mucosal type of inactive Chronic Otitis Media. Done using a post aural route and temporalis fascia graft |
| Comparator Agent |
Type 1 Tympanoplasty with autologous PRP enriched post operative packing |
Type 1 Tympanoplasty with autologous PRP enriched post operative packing |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.All cases of Chronic Otitis Media(COM) Mucosal type needing Type 1 tympanoplasty
2.Dry central perforation from last 3 months
3.Healthy middle ear mucosa |
|
| ExclusionCriteria |
| Details |
1.COM Squamous
2.Active ear discharge
3.Ossicular chain defect/pathology
4.Presence of overt complications of COM
5.Revision surgery of COM |
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tympanoplasty Graft Uptake Rate |
03 Months Post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hearing loss as judged by Pure TOne audiometry |
03 months post operative |
|
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Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
18/02/2019 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
References:1)Erkilet E, Koyuncu M, Atmaca S, Yarim M. Platelet-rich plasma improves healing of tympanic membrane perforations: experimental study. The Journal of Laryngology & Otology. 2009 May;123(5):482-7
2) El-Anwar MW, El-Ahl MA, Zidan AA, Yacoup MA. Topical use of autologous platelet rich plasma in myringoplasty. Auris Nasus Larynx. 2015 Oct 1;42(5):365-8.
3) Sankaranarayanan G, Prithiviraj V, Kumar RV. A study on efficacy of autologous platelet rich plasma in myringoplasty. Otolaryngology online journal. 2013 May 10;3(3):1-5.
4) Stavrakas M, Karkos PD, Markou K, Grigoriadis N. Platelet-rich plasma in otolaryngology. The Journal of Laryngology & Otology. 2016 Dec;130(12):1098-102.
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Chronic Otitis Media (COM) is a common ailment in the country and a leading cause of treatable deafness. It is defined as chronic inflammation of the mucosal lining of the middle ear cleft. In the mucosal type of COM, there is a permanent perforation of pars tensa. Surgery in the form of Tympanoplasty is the standard of care of such patients. A common cause of failure of this surgery includes graft failure. Platelet-rich plasma (PRP) is emerging biotechnology and a simple and minimally invasive method to obtain a high concentration of autologous growth factors at sites of healing. The usage of PRP as a topical packing material in Type 1 Tympanoplasty has been reported to enhance the graft uptake and closure rate of perforation as compared to traditional method. However, the data available is limited and no properly conducted RCTs are available to provide evidence of this adjuvant to surgery.
Accordingly, it is hypothesised that using autologous PRP as an adjuvant to standard treatment (type 1 Tympanoplasty) would enhance healing rates and minimise graft failures. The present study will get the much-needed level of evidence to prove a simple and efficacious adjuvant to improve outcomes of this common disorder.
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