ENT

1. SYNOPSIS
DEPARTMENT OF OTORHINOLARYNGOLOGY CHIRAYU MEDICAL
COLLEGE AND HOSPITAL,BHOPAL, M.P.
“A Comparative Study Of Temporalis Fascia in Myringoplasty With Or Without
Platelat Rich Fibrin At A Tertiary Care Centre Of Central India”
GUIDE CO-GUIDE
DR. RAKESH MARAN DR. MAHESH C. PATIL
PROFESSOR DEPARTMENT PROFESSOR
OF OTORHINOLARYNGOLOGY DEPARTMENT OF PATHOLOGY
CHIRAYU MEDICAL COLLEGE AND HOSPITAL CHIRAYU MEDICAL COLLEGE
COLLEGE,BHOPAL(M.P.). AND HOSPITAL,BHOPAL(M.P.).
PRINCIPAL INVESTIGATOR
DR. PULKIT SHARMA
P.G RESIDENT 1st YEAR
CHIRAYU MEDICAL COLLEGE AND HOSPITAL
BHOPAL (M.P).

2. Introduction
• Chronic suppurative otitis media is defined as chronic mucoperiosteal inflammation of middle
ear cleft and mastoid cavity which presents with recurrent ear discharge or otorrhea through a
permanent tympanic membrane perforation for a period of more than 3 months[1].
• The diagnosis of chronic otitis media implies that there is permanent abnormality of pars
tensa or flaccida which results from previous acute otitis media or negative middle ear
pressure or otitis media with effusion.
• Chronic Suppurative Otitis Media (CSOM) is an inflammatory process in the middle-ear
space that results in permanent changes in the tympanic membrane that may lead to
atelectasis, perforation, tympanosclerosis, retraction pocket, or cholesteastoma.
• The most common bacteria isolate of chronic otitis media is Pseudomonas[2].

3. • It is a widespread disease of the developing countries, like India. Globally, the prevalence of chronic
suppurative otitis media is 65-330 million people, and 39-200 million (60%) suffer from clinically
significant hearing impairment [3].
• Tympanic perforations result from multiple causes, including infection and trauma, and its regeneration
is a process complex that includes epithelial proliferation, cell migration, fibroblast proliferation and
angiogenesis ending in remodeling tissue. When these do not heal after three months, can cause
complications serious, such as recurrent otitis media or even hearing loss, so there is the need for surgery
and the use of grafts to repair them. Myringoplasty is a surgical procedure performed only on the
tympanic membrane, without ossicular reconstruction[4].
• whereas, Tympanoplasty involves eradication of middle ear disease and reconstruction of hearing
mechanism including Tympanic membrane and ossicles[5].
• One of the most frequent procedures performed on the middle ear is tympanoplasty. In the surgical repair
of perforations of tympanic membrane several variables come into play such as size of perforation,
overhang, eustachian tube function, state of the mucosa, wound healing, degree of pneumatization
etc.[6].

4. • Wullstein and Zollner created the fundamental principles of tympanoplasty. Ear surgery has been
focused on restoring function and creating a stabilised, problem-free ear [7].
• Various graft materials are available for closing the tympanic membrane perforation. Most
commonly used grafting material is temporalis fascia graft. Other materials that can be used are
vein, areolar tissue over temporalis fascia, tragal perichondrium, periosteum over mastoid process,
meatal skin from bony external auditory meatus, split skin, fat, cartilage, xenografts like bovine
pericardium and treated acellular dermal homograft‘s etc. can be used [8].
• Platelet-rich fibrin is a second-generation platelet concentrate, which is rich in platelets, cytokines,
growth factors, and leukocytes that are trapped and released over a period. It serves as a resorbable
membrane that offers both mechanical and inflammatory protection to the tympanic membrane [9].
• As for platelet-rich fibrin, it has many advantages, such as safety be an autologous material, greater
deposition of growth factors and platelets in a specific area and short preparation time, in addition
to offering inflammatory protection and mechanics to grafts and accelerate proliferation cell, as
well as preparation and easy obtaining with easy handling during the procedure surgical.
• Autologous platelet-rich plasma is easy to prepare and handle, and no associated side effects
have been reported [10].

5. • RESEARCH QUESTIONS
What are the benefits and success rate of Platelet Rich Fibrin (PRF) applied in Temporalis
Fascia as a graft material in Myringoplasty.
• AIM
To compare the efficiency of autologous platelet rich fibrin with Temporalis Fascia as a graft material in
closure of tympanic membrane perforation during Myringoplasty.
• OBJECTIVES
1.To evaluate the success rate of the Platelet Rich Fibrin (PRF) and Temporalis Fascia as a graft material in
Myringoplasty.
2.To assess the benefits of Platelet Rich Fibrin (PRF) applied in Temporalis Fascia graft in terms of
improvement in hearing after Myringoplasty.

6. METHODOLOGY:-
• 100 Patients attending Chirayu medical College having history of ear discharge will be evaluated.
• Detailed history will be taken from the patients and the information will be obtained including socio-
demographic characteristics,symptoms, duration of symptoms,recurrent Sino-nasal symptoms (if any) and the
information will be entered in the master chart.
• These patients will undergo ENT examination, and if found to be having Inactive Chronic Suppurative Otitia
Media (CSOM), which will be confirmed by Otoscopic examination, Tuning Fork tests, X-ray mastoid and Pure
Tone Audiometry( PTA), will be included in the study after obtaining informed consent.
• Prospective study over 80 patients, divided into 2 group according to graft material used.
PREPARATION PLATELET RICH FIBRIN (PRF)
• 10 ml blood will withdrawn from patient just before the surgery. The sample will centrifuged at 3000 rpm for 25
min which formed platelet-rich fibrin in the middle of the tube. Platelet rich fibrin obtained. The blob of Platelet
rich fibrin will placed between two glass slides and gently pressed for about three minutes.
OPERATIVE TECHNIQUE
• The underlay technique involves placement of the Temporalis Fascia graft medial to the entire tympanic
membrane, with elevation of a flap of ear canal skin together with the drumhead being most commonly
used for access, stabilizing the graft under the fibrous annulus. Platelet Rich fibrin will be placed on
graft. Ear canal was packed with abgel soaked in antibiotic drop.

7. FOLLOW UP
• Patient will follow up at 4-week, 6 week, and 12 weeks and post-op Pure Tone Audiometry
(PTA) will be done at 12 week and graft condition will be assessed.
STUDY DESIGN
• Hospital based prospective study.
STUDY DURATION
• 18 Months (MARCH 2023 - SEPTEMBER 2024)
STUDY SETTING
• Study will be conducted in OTORHINOLARYNGOLOGY(ENT) Department, Chirayu
Medical College & Hospital Bhopal (M.P.) India , after approval by Research and Ethics
Committee over a period of 18 months.

8. INCLUSION CRITERIA
• Patient who is ready to give informed written consent for surgery.
• Patient 18 year and above with Small Central Perforation (SCP) of tympanic membrane will included in this study.
• Patient with inactive Mucosal Chronic Suppurative Otitis Media (CSOM).
• Patient with mild conductive hearing loss
EXCLUSION CRITERIA
• Patient who does not ready to give informed written consent for surgery.
• Patient below 18 year will excluded in this study.
• Patient with active Mucosal and UNSAFE Chronic Suppurative Otitis Media (CSOM).
• Patient with mixed hearing loss and Sensorineural Hearing Loss(SNHL).
• Revision myringoplasty
STUDY POPULATION
• GROUPA: Myringoplasty with Temporalis fascia as a graft(50 Patient)
• GROUP B: Myringoplasty with Platelet Rich Fibrin applied in Temporalis Fascia as a graft(50 Patient)
SAMPLE SIZE
• A sample size of 100 patients (i.e., 50 in each group).
DATA ANALYSIS
• Data will be analyzed using appropriate statistical test of significance and appropriate statistical software like SPSS
(Statistical Package for Social Science) software as per requirement.

9. ETHICAL CONSIDERATION
• Approval will be taken from Institutional Research and Ethics Committee.
• Identity of the patient will be kept confidential.
• Written Informed consent will be taken from Parents/Guardian.
INFORMED CONSENT FORM IN HINDI AND ENGLISH
• Enclosed.
FINANCIAL IMPLICATION
• There is NO financial implication.
• Study will be part of treatment.
CONFLICT OF INTEREST
• There are NO conflicts of interest.

10. REFERENCES:-
1.Nair NP, Alexander A, Abhishekh B, Hegde JS, Ganesan S, Saxena SK. Safety and efficacy of autologous
platelet-rich fibrin on graft uptake in myringoplasty: a randomized controlled trial. International archives of
otorhinolaryngology. 2019 Jan;23(01):077-82.
2.Jahn AF. Chronic otitis media: diagnosis and treatment. The Medical clinics of North America. 1991 Nov
1;75(6):1277-91.
3. Monasta L, Ronfani L, Marchetti F, et al; Burden of disease caused by otitis media: systematic review and
global estimates. PLoS One. 20127(4): -36226. Epub 2012 Apr 30.
4. Sarkar, S., 2013 Dec. A review on the history of tympanoplasty. Indian J. Otolaryngol. Head Neck Surg. 65
(Suppl. 3). 455-460.
5. A. Akyigit et al. Endoscopic tympanoplasty, Journal of Otology 12 (2017) 62-6.
6. Glasscock and Shambaugh. "Tympanoplasty", In Glasscock and Shambaugh, Surgery of the Ear 5th edition,
chapter, 2003; 16:350-370.
7. Sismanis A (2003) Tympanoplasty Glasscock-Shambaugh surgery of the ear", Chap 24. BC Decker Inc,
Hamilton.

11. 8. Kumar N, Chilke D, Puttewar MP. Clinical profile of tubotympanic CSOM and its management with special
reference to site and size of tympanic membrane perforation, Eustachian tube functions and three flap tympanoplasty.
Indian J Otolaryngology Head Neck Surg. 2012; 64(1):5- 12.
9. Nair NP, Alexander A, Abhishekh B, Hegde JS, Ganesan S, Saxena SK. Safety and Efficacy of Autologous Platelet-
rich Fibrin on Graft Uptake in Myringoplasty: A Randomized Controlled Trial. Int Arch Otorhinolaryngol.
2019;23(1):77-82.
10.El-Anwar MW, Elnashar I, Foad YA. Platelet-rich plasma myringoplasty: A new office procedure for the
repair of small tympanic membrane perforations. Ear Nose Throat J. 2017;96(8):312-326.

12. PARTICIPANT INFORMATION SHEET:-
TITLE OF THE STUDY “A Comparative Study Of Temporalis Fascia In Myringoplasty With Or Without Platelat
Rich Fibrin At A Tertiary Care Centre Of Central India”
PATIENT’S NAME-
INTRODUCTION TO RESEARCH STUDY-
PURPOSE OF THE STUDY:
WHO CAN TAKE PART:
WHO WILL BE CONDUCTING THE STUDY:
MY ROLE/RESPONSIBILITY IN THE STUDY:
PARTICIPATION IS VOLUNTARY:
TOTAL STUDY DURATION:
RISKS AND DISCOMFORTS OF THE STUDY:
BENEFITS OF THE STUDY:
PARTICIPATION OF THE STUDY KEPT CONFIDENTIAL:
Name of the Principal investigator :- DR. PULKIT SHARMA
Sign-
Date –
Designation – PG RESIDENT FIRST YEAR
Department of :- OTORHINOLARYNGOLOGY
Chirayu Medical College ad Hospital,
Bhopal, (M.P.)

13. Informed consent document (ICD) in English and the local language(s).
Consent Form
Participant identification number for this trial:Title of project, “A Comparative Study Of Temporalis
Fascia In Myringoplasty With Or Without Platelat Rich Fibrin At A Tertiary Care Centre Of Central
India”
Name of Principal Investigator .Dr. _____________Tel. No(s). ____
The contents of the information sheet dated ……………….. that was provided
have been read carefully by me / explained in detail to me, in a language that I comprehend, and I have
fully understood the contents. I confirm that I have had the opportunity to ask questions.
The nature and purpose of the study and its potential risks / benefits and expected duration of the study,
and other relevant details of the study have been explained to me in detail. I understand that my
participation is voluntary and that I am free to withdraw at any time, without giving any reason, without
my medical care or legal right being affected.
I understand that the information collected about me from my participation in this research and sections
of any of my medical notes may be looked at by responsible individuals from Chirayu Medical College
and Hospital Bhopal,(M.P.). I give permission for these individuals to have access to my records.
I agree to take part in the above study.
--------------------------------------------- Date:
(Signatures / Left Thumb Impression) Place:
Name of the Participant: ____________
Son / Daughter of ____________
Complete postal address: _____________
This is to certify that the above consent has been obtained in my presence.
Witness
------------------------------
Signature
Name:
Address:
Date: Date:
Signature of the Principal Investigator
Place:

14. सहमति पत्र
अध्ययन क्रम ांक ..................
अध्ययन विषय: , “A Comparative Study Of Temporalis Fascia In Myringoplasty With Or Without Platelat Rich Fibrin At A Tertiary Care Centre Of
Central India”
उपययुक्त शोध क
े अध्ययन क
े विए प्रविभ गी पहच न क्रम ांक ............... को शोधक यु क
े ब िि् इस्तेम ि कर ज िेग l इस शोध की प्रमयख अन्वेषक DR.PULKIT SHARMA
है वजनक मोब ईि नां 9427672929 है l
मैं यह घोवषि करि /िी हां की;
1.यह की मैंने उपरोक्त शोधक यु ब िि् ज नक री पत्र विन ांक ............. को पढ़ एिां समझ विय है / वजसक मयझे सम्पूर्ु वििरर् मेरी भ ष में बि एिां समझ विय गय है और
मयझे हर सि ि को पूछने क पय ुप्त समय विय गय और मेरी सांियवि की l
2.यह की मयझे उपययुक्त शोधक यु से जयड़े हुए सांभ विि जोखखम/ फ यिे और सांभ विि िक़्त जो इस शोधक यु में िग सकि है िह मयझे सवििरर् समझ विय गय है l
3.मैं यह भी जनि /िी हां की मेरी इस शोध मैं प्रविभ वगि पूर्ु रूप से स्वेखिक है एिां मैं वकसी भी समय वबन कोई क रर् विए अथि बि ए इस शोधक यु से अपनी
प्रविभ वगि वनरस्त कर सकि / िी हां एिां उससे मेरे उपच र पर वकसी िरह क कोई प्रभ ि नहीांपड़ेग एिां न ही वकसी िरह से वचवकत्स एिां उपच र से जयड़े मेरे मौविक
अवधक रोां क उल्लांघन होग l
4.यह की मेरे द्व र िी गई ज नक री क इस्तम ि उपययुक्त शोधक यु क
े ब िि् होग और इससे जयडी समस्त ज नक री को विम्मेि र व्यखक्त द्व र , जो वचर यय मेवडकि कॉिेज एिां
हॉखिटि , भोप ि (म.प्र.), क
े द्व र िेख ज सकि और मैं इसकी अनयमवि िेि / िी हां l
5.यह की मैंने उपययुक्त शोधक यु हेिय अपनी प्रविभ वगि क
े विए स्वेि से अपनी सहमवि प्रि न करि / िी हां l
............................................... ि रीख
(िस्तखि/ ब एँ अांगूठे क वनश न) स्थ न
प्रविभ गी क पूर न म :..............................
जन्मविवथ एिां उम्र :..../......./......
पि :....................
यह प्रम वर्ि वकय ज ि है की उपययुक्त सहमवि मेरी उपखस्थवि मैं िी गयी है l
-------------------------------
(गि ह क
े िस्तखि)
गि ह क न म : .............................
पि : ...................................
विन ांक : ................................
.............................................
(प्रमयख अन्वेषक क
े िस्तखि) विन ांक स्थ न

15. Proforma for Clinical Data Collection
CASE PROFORMA SHEET
OPD: …………………….. IPD:……………………………….
Patient Name:…….............S/O, D/O, W/O…………………….
AGE: …………… SEX: M/F/T…….OCCUPATION: ……….
ADDRESS: ………………………….MARITAL STATUS: M/U……
D.O.A ……………………D.O.D………………….
Religion: …………… MOBILE:………………….
DIAGNOSIS………………………………………..
CHIEF COMPLAINTS:
1…………………………………………………….
2…………………………………………………….
3…………………………………………………….
4…………………………………………………….
HOPI:
1. EAR DISCHARGE:
ONSET INSIDIOUS/SUDDEN
DURATION ………………………………
PROGESSION PROGRESSIVE/NONPROGRESSIVE
QUANTITY COPIOUS/SCANTY
SMELL FOUL/NON-FOUL
CONSISTENCY
MUCOID/PURULENT/MUCOPURULENT
BLOOD STAINED YES/NO
FREQUENCY INTERMITTENT/CONTINUOUS

16. 1.LAST EAR DISCHARGE …………………………………….
2. PAIN IN EAR: YES/NO
3. DECREASED HEARING YES/NO
4. RECURRENT URTI YES/NO
5. TONSILLITIS ……….
6. ITCHING: YES/NO
7. FEVER: YES/NO
8. TINNITUS: YES/NO
9. GIDDINESS: YES/NO
10.HEADACHE YES/NO
11.FACIAL WEAKNESS: YES/NO
12.ALLERGIC HISTORY: YES/NO
PAST HISTORY:
HISTORY OF SIMILAR COMPLAINS, SURGERY……………………
FAMILY HISTORY:………………………………………………………...
HISTORY OF SIMILAR COMPLAINS ………………………………….
PERSONAL HISTORY: APPETITE …………………..DIET……………

17. SLEEP …………………………….BLADDER/BOWEL ………….
ADDICTION ………………………………….
HYPERTENSION, DIABETES, TB, ASTHMA, BLOODTRANSFUSION…………….
MENSTRUAL H/O ……………………………
IMMUNIZATION H/O ………………………..
EAR EXAMINATION:-
TUNING FORK TEST:-
Rinne Test (256Hz)
Rinne Test (512Hz)
Rinne Test (1024Hz)
Weber Test
Absolute Bone Conduction

18. Haemoglobin
Platelet Count
RIGHT EAR LEFTEAR
PURE TONE
AUDIOMETRY
FREQUENCYAVERAGE
AB GAP
NOSE:
ORAL CAVITY:
INVESTIGATIONS: -
•PATHOLOGY:
•AUDIOLOGY:

19. X - RAY MASTOID
RIGHT EAR LEFT EAR
OSSICULAR MOBILITY
EUSTACHIAN TUBE ORIFICE
MIDDLE EAR MUCOSA
PROMONTORY
ROUND WINDOW REFLEX
•RADIOLOGY:
INTRA OP FINDINGS:-
FOLLOW UP: -
4 WEEKS
6 WEEKS
12 WEEKS

20. POST OP – PURE TONE AUDIOMETRY:-

21. TOPIC OF THESIS
“A Comparative Study Of Temporalis Fascia In Myringoplasty With Or Without Platelat Rich
Fibrin At A Tertiary Care Centre Of Central India”

22. Details Name Designation Department Mobile no. E-mail ID Signature
Principal
Investigator
DR.PULKIT
SHARMA
P.G.
RESIDENT 1ST
YEAR
ENT 9427672929 spulkitsharma@gmail.com
Co-
Investigator/
Guide
DR.RAKESH
MARAN
PROFESSOR ENT 8120142375 drrakeshmaran@gmail.com
Co-Guide DR.MAHESH
C PATIL
PROFESSOR PATHOLOGY 9618613452 maheash12july@gmail.com
CHIRAYU MEDICAL COLLEGE AND HOSPITAL, BHOPAL, (M.P.)
Research Committee
DECLARATION BY THE INVESTIGATOR
I/We the undersigned solemnly declare that the project Submitted “A Comparative Study Of Temporalis Fascia In
Myringoplasty With Or Without Platelat Rich Fibrin At A Tertiary Care Centre Of Central India”
is based on my/ our own work to be carried out during the course of our study.
I /We assert the statements made and conclusions drawn are an outcome of my/our research work. I further certify that
1. The work contained in the report is original
•The work has not been submitted for publication
•We will be following the protocol provided for the project
•Whenever we will use materials (data, theoretical analysis, and text) from other sources, we give due credit to them in the
text of the report and giving their details in the references.
•We will acknowledge the help provided by others (as & when needed) we agree to the sequence of authorship as mentioned
bellow

23. SECTION E: DECLARATION AND CHECKLIST
11. DECLARATION (Please tick as applicable)
I/We certify that the information provided in this application is complete and
correct.
I/We confirm that all investigators have approved the submitted version of
proposal/related documents.
I/We confirm that this study will be conducted in accordance with the latest
ICMR National Ethical Guidelines for Biomedical and Health Research
involving Human Participants and other applicable regulations and guidelines
including responsible.
I/We confirm that this study will be conducted in accordance with the Drugs
and CosmeticsAct 1940 and its Rules 1945 as amended from time to time, GCP
guidelinesand other applicable regulations and guidelines.
I/We will comply with all policies and guidelines of the institute and
affiliated/collaborating institutions where this study will be conducted.

24. I/We will ensure that personnel performing this study are qualified,
appropriatelytrained and will adhere to the provisions of the EC approved
protocol.
I/We declare that the expenditure in case of injury related to the study will be
takencare of.
If applicable, I/We confirm that an undertaking of what will be done with the
leftoversamples is provided, if applicable.
I/We confirm that we shall submit any protocol amendments, adverse events
report, significant deviations from protocols, progress reports (if required) and
a final reportand also participate in any audit of the study if needed.
I/We confirm that we will maintain accurate and complete records of all
aspects ofthe study.
I/We will protect the privacy of participants and assure safety and
confidentiality ofstudy data and biological samples.

25. I/We hereby declare that I/any of the investigators, researchers and/or close
relative(s), have no conflict of interest (Financial/Non-Financial) with the
sponsor(s)and outcome of study.
I/We have the following conflict of interest (PI/Co-PI):
I/We declare/confirm that all necessary government approvals will be obtained
as perrequirements wherever applicable.
Name of PI: DR.PULKIT SHARMA Signature: Date-
NAME OF CO-GUIDE:DR.MAHESH C.PATIL Signature: Date-
Name of Guide: DR.RAKESH MARAN Signature: Date-
Name of HOD: DR.ANIL KUMAR JAIN Signature: Date-

26. THANK YOU