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CTRI Number  CTRI/2024/05/066644 [Registered on: 01/05/2024] Trial Registered Prospectively
Last Modified On: 12/06/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Use of Platelet Rich Fibrin Membrane (PRF) in Type 1 Tympanoplasty 
Scientific Title of Study   Use of Platelet Rich Fibrin Membrane (PRF) reinforcement in Type 1 Tympanoplasty 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrBhagyesh LDarji 
Designation  Assistant Professor 
Affiliation  Dr.N.D.Desai Faculty of Medical Sci. and research,Nadiad 
Address  Dr.Bhagyesh Darji Dept. OF ENT, Dr.N.D.Desai Faculty of Medical Sci.and research,Nadiad-387001

Kheda
GUJARAT
387001
India 
Phone  9953897332  
Fax    
Email  bhagyesh.darji@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrBhagyesh LDarji 
Designation  Assistant Professor 
Affiliation  Dr.N.D.Desai Faculty of Medical Sci. and research,Nadiad 
Address  Dr.Bhagyesh Darji Dept. OF ENT, Dr.N.D.Desai Faculty of Medical Sci.and research,Nadiad-387001


GUJARAT
387001
India 
Phone  9953897332  
Fax    
Email  bhagyesh.darji@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrBhagyesh LDarji 
Designation  Assistant Professor 
Affiliation  Dr.N.D.Desai Faculty of Medical Sci. and research,Nadiad 
Address  Dr.Bhagyesh Darji Dept. OF ENT, Dr.N.D.Desai Faculty of Medical Sci.and research,Nadiad-387001


GUJARAT
387001
India 
Phone  9953897332  
Fax    
Email  bhagyesh.darji@gmail.com  
 
Source of Monetary or Material Support  
Dharmsinh Desai University 
 
Primary Sponsor  
Name  Dharmsinh Desai University 
Address  Dharmsinh Desai University,College Road,Nadiad 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrBhgyesh Darji  Dr.N.D.desai Faculty of medical science and research  Department of ENT,room no 207,DrDr.N.D.desai Faculty of medical science and research,Nadiad
Kheda
GUJARAT 		 9953897332

BHAGYESH.DARJI@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr.N.D.Desai Faculty of medical science and research,Dharmsinh Desai university INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H720||Central perforation of tympanic membrane,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Only Graft material (temporalis facia or perichondrium)  No addition Of PRF on Graft in Type 1 Tympanoplasty in 30 patients,over the period of 6 months 
Intervention  Use of Platelet Rich Fibrin membrane   Apart from using graft for type 1 tympanoplasty; additional PRF membrane will be used for 30 patients,over the period of 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients with age of 18 to 50years.
Having tubotympanic type of CSOM with central perforation
Having dry ear for 6 weeks
Voluntarily agree to participate with consent.
 
 
ExclusionCriteria 
Details  Patients having complicated CSOM
Patients with ossicular chain erosion
Patients with cholesteatoma
Not fit for surgery/Not willing for surgery
Patient having SNHL or Mixed Hearing Loss
Revision surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Success rate of graft uptake in Group with PRF(%)

2.Success rate of graft uptake in Group without PRF(%)
 		 Preoperative and Post op 3 months assessment
 
 
Secondary Outcome  
Outcome  TimePoints 
Hearing improvement in either group
Pre operative and Post operative (3 months post op) audiogram will be compared to see AB gap closure.(mean of AB gap closure)
 		 Preoperative and Post op 3 months assessment 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/05/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Published in Indian Journal of Otolaryngology and Head & Neck Surgery https://doi.org/10.1007/s12070-026-06653-y Title:Use of Platelet-Rich Fibrin (PRF) Membrane Reinforcement in Type 1 Tympanoplasty: A Randomized Controlled Trial 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Summary/Purpose

Tympanoplasty is the surgery performed in Chronic Otitis Media (COM) to improve the hearing function and prevent ear discharge. Platelet Rich Fibrin (PRF) is one of the materials that can be used to improve the graft uptake and hearing outcome. It is obtained by centrifugation of blood. The PRF contains leukocytes, cytokines, structural glycoproteins and growth factors which accelerates healing. It has been used in various surgical procedures to improve the outcome.

Platelet-rich fibrin (PRF) which is considered a second-generation platelet-rich plasma having a high content of growth factors could be implied as a sealant and adjuvant to grafting materials during tympanoplasty operation [1].

 

Tympanoplasty has been treated with various materials since its initial technique described by Berthold in 1878 where the remnant tympanic membrane was deepithelialized and a skin graft was applied over the defect.[2]

Various modifications of the graft materials were done since then by Zollner (1954), Frenckner (1955), Shea (1960) Heermann (1960), and many other surgeons. The fundamental principles of the surgical procedure were first described by Wullstein in 1952, using a free skin graft, and Zoellner in 1955, using a pedicle graft.[3]

Since then, several types of materials have been used to reconstruct the tympanic membrane, temporalis fascia, fascia lata, periosteum, perichondrium, cartilage with and without perichondrium, veins, fatty tissue, and skin.[4] Other allografts mentioned in the literature include dura mater, pericardium, amniotic membrane, skin, cornea, peritoneum, veins, and aortic valve.[5]

Recently, alloplastic grafts such as paper, absorbable gelatin sponge, and acellular dermal matrix have also been used.[6]

Each of the techniques was associated with its own advantages and disadvantages. However, fascia temporalis is the most commonly used graft, with success rates between 93% and 97% in primary tympanoplasty, especially in well-aerated middle ears.[7,8]

Although the literature shows the type of graft material used for closure of tympanic membrane (TM) perforations has been shown to have an effect on the outcome of surgery, there are no consistent success rates for achieving an intact tympanic membrane after surgery using different surgical techniques.[9]

A study by Kütük et al. in 2019, with 91 patients randomized into two groups; temporalis fascia graft alone and temporalis fascia with PRP, found better graft survival rates in patients who had temporalis fascia with PRP therapy, especially in those with larger perforations. Reperforations were noted in those who had more than 50% perforation preoperatively. Although hearing gain was greater in those patients who received PRP therapy, it was not statistically significant between the two groups.[10]

A study by S. Yadav et al. reported 95% graft uptake and 18.62 dB hearing improvement in PRF group, while 85% graft uptake and 13.15dB hearing improvement in no PRF group.[11]

A similar study done in India by Shanmugam R et al. proved the superiority of using PRF, showing 100% graft uptake with usage of PRF and hearing improvement of 13.75 dB.[12]

Kaur reported that PRF aids in the initial stability of the grafted tissue at the recipient sites. PRF allows rapid vascularization of the healing tissue by delivering growth factors that induce regeneration. The regeneration occurred due to super-saturation of the wound with PRF, growth factors [13].

Habesoglu et al. [14] in their study on closure of acute tympanic perforations concluded that the use of platelet-rich fibrin accelerates the tympanic membrane closure.

Garin et al. [15] also observed good safety of platelet rich fibrin without any adverse effect in middle ear packing.

References:

1. Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J et al (2006) Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endodontol 101(3):e37– e44

2. Sarkar S. A review on the history of tympanoplasty. Indian J Otolaryngol Head Neck Surg 2013;65:455-60.

3. Zollner F. The principles of plastic surgery of the sound-conducting apparatus. J Laryngol Otol 1955;69:637-52.

4. Lee JC, Lee SR, Nam JK, Lee TH, Kwon JK. Comparison of different grafting techniques in type I tympanoplasty in cases of significant middle ear granulation. Otol Neurotol 2012;33:586-90.

5. Van Rompaey V, Farr MR, Hamans E, Mudry A, Van de Heyning PH. Allograft tympanoplasty: A historical perspective. Otol Neurotol 2013;34:180-8.

6. Haynes DS, Vos JD, Labadie RF. Acellular allograft dermal matrix for tympanoplasty. Curr Opin Otolaryngol Head Neck Surg 2005;13:283-6.

7. Malhotra M, Varshney S, Malhotra R, Joshi P. Indian perspectives on graft materials used for repair of tympanic membrane. J Clin Diagn Res 2017;11:ME01-6.

8. Kulkarni S, Kulkarni V, Burse K, Sancheti V, Roy G. Cartilage support for fascia graft in type I tympanoplasty. Indian J Otolaryngol Head Neck Surg 2014;66:291-6.

9. Indorewala S, Adedeji TO, Indorewala A, Nemade G. Tympanoplasty outcomes: A review of 789 cases. Iran J Otorhinolaryngol 2015;27:101-8.

10. Kütük SG, Özdaş T. Impact of platelet-rich fibrin therapy in tympanoplasty type 1 surgery on graft survival and frequency-specific hearing outcomes: A retrospective analysis in patients with tympanic membrane perforation due to chronic otitis media. J Laryngol Otol 2019;133:1068-73.

11. Yadav SP, Malik JS, Malik P, Sehgal PK, Gulia JS, Ranga RK. Studying the result of underlay myringoplasty using platelet-rich plasma. J Laryngol Otol. 2018;132(11):990-994. doi: 10.1017/S0022215118001846

12. Shanmugam R, Gnanavelu Y, Shanmugam VU, Swaminathan B, Nivas P, Bharath I. Myringoplasty with Autologous Platelet Rich Plasma - A prospective study. J Med Sci Clin Res. 2018;6(10):1170-1173. doi: 10.18535/ jmscr/v6i10.196

13. Kaur P (2011) Platelet-rich fibrin a novel bioengineering concept. Trends Biomater Artif Organs 25:86–90

14. Habesoglu M, Oysu C, Sahin S, Sahin-Yilmaz A, Korkmaz D, Tosun A, Karaaslan A. Platelet-rich fibrin plays a role on healing of acute-traumatic ear drum perforation. J Craniofac Surg. 2014;25(6):2056–2058. doi: 10.1097/SCS.0000000000001140. [PubMed] [CrossRef] [Google Scholar]

15. Garin P, Mullier F, Gheldof D, Dogne JM, Putz L, Van Damme JP. Platelet-rich fibrin (PRF): an autologous packing material for middle ear microsurgery. B-ENT. 2014;10(01):27–34. [PubMed] [Google Scholar]


 
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