Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609616749959 Date of Registration: 04/09/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Outcomes of Underlay Fascial Tympanoplasty With and Without Platelet-Rich Plasma: A Randomized Controlled Trial
Official scientific title Comparative Outcomes of Underlay Fascial Tympanoplasty With and Without Platelet-Rich Plasma: A Prospective Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Tympanic membrane perforation is a common otological condition that may result in recurrent ear discharge and conductive hearing loss, and tympanoplasty is performed to restore the integrity of the tympanic membrane and improve hearing. Platelet-rich plasma (PRP) contains growth factors that may enhance tissue healing and graft integration; however, its clinical efficacy as an adjunct to conventional underlay fascial tympanoplasty remains uncertain. This study evaluates the efficacy of PRP as an adjunct to underlay fascial tympanoplasty in patients with chronic tympanic membrane perforation. Thirty patients were randomized equally into two groups: one underwent conventional underlay tympanoplasty using temporalis fascia alone, while the other received the same procedure augmented with PRP. The primary outcome was complete tympanic membrane closure at 3 months postoperatively. Secondary outcomes included air-bone gap reduction, functional success rate (ABG gain >10 dB), and complications. The study was conducted at Capital University Hospital (Badr Hospital), Egypt, from April 2024 to December 2024.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/04/2024
Actual trial start date 01/04/2024
Anticipated date of last follow up 01/12/2024
Actual Last follow-up date 01/12/2024
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
732024 ethics committee faculty of medicine capital universty
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Underlay Fascial Tympanoplasty not applicable Single surgical procedure Patients in the control group underwent conventional underlay fascial tympanoplasty without adjunctive platelet-rich plasma application. Patients received the same postoperative care and follow-up schedule as the experimental group. 15 Active-Treatment of Control Group
Experimental Group Platelet Rich Plasma Assisted Underlay Fascial Tympanoplasty Single intraoperative topical application of autologous PRP Single application during the surgical procedure Patients in the experimental group underwent underlay fascial tympanoplasty with adjunctive application of autologous platelet-rich plasma (PRP) during surgery. The PRP was applied to the graft site as an adjunct to conventional underlay fascial tympanoplasty. Patients subsequently received the same postoperative care and follow-up schedule as the control group. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged 12–60 years Tympanic membrane perforation requiring tympanoplasty Male or female patients Willing to undergo tympanoplasty Provided informed written consent Age below 12 years or above 60 years Active middle ear infection Chronic systemic illnesses affecting wound healing, including ischemia, diabetes mellitus, or venous stasis disease Non-compliant patients Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/07/2024 Research Ethics Committe REC for Human and Animal Research at the Faculty of Medicine Helwvan University
Ethics Committee Address
Street address City Postal code Country
Helwan Cairo 11795 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Complete tympanic membrane closure (graft uptake) at 3 months postoperatively Preoperatively, 1 month postoperatively, and 3 months postoperatively
Secondary Outcome Air-bone gap (ABG) reduction following tympanoplasty Preoperatively, 1 month postoperatively, and 3 months postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Otorhinolaryngology Department Faculty of Medicine Capital University cairo egypt helwan cairo 11795 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Christina Nagah GadElsayd AbdElmaseeh helwan cairo 11795 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Capital university cairo Egypt Helwan Cairo 11795 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Christina AbdElmaseeh christina_emaseh@med.capu.edu.eg +201289549245 Down town
City Postal code Country Position/Affiliation
Cairo 11511 Egypt Principal Investigator Faculty of Medicine Capital University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elsheikh elsheikh.mohamed2020@med.helwan.edu.eg +201222421968 Nasr city
City Postal code Country Position/Affiliation
Cairo 11371 Egypt Professor doctor
Role Name Email Phone Street address
Public Enquiries Mohamed Hamed mohamed.hamed@med.helwan.edu.eg +201228555380 Maadi
City Postal code Country Position/Affiliation
Cairo Egypt Professor doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data including demographic characteristics, clinical findings, audiological results, and postoperative outcomes will not be publicly shared. Anonymized individual participant data may be made available upon reasonable request, subject to ethical and institutional approval. Study Protocol Anonymized individual participant data may be considered for sharing after publication of the study and following reasonable request, subject to ethical and institutional approval Access will be considered for researchers with a scientifically justified request. Requests will be reviewed by the principal investigator and relevant institutional authorities, and data will only be shared in an anonymized form when ethically and legally permissible.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 26/08/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 26/08/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 18/08/2026 To provide a brief background about your study and not only how it was conducted as requested by PACTR reviewer This study evaluates the efficacy of platelet-rich plasma (PRP) as an adjunct to underlay fascial tympanoplasty in patients with chronic tympanic membrane perforation. Thirty patients were randomized equally into two groups: one underwent conventional underlay tympanoplasty using temporalis fascia alone, while the other received the same procedure augmented with PRP. The primary outcome was complete tympanic membrane closure at 3 months postoperatively. Secondary outcomes included air-bone gap reduction, functional success rate (ABG gain >10 dB), and complications. The study was conducted at Capital University Hospital (Badr Hospital), Egypt, from April 2024 to December 2024. Tympanic membrane perforation is a common otological condition that may result in recurrent ear discharge and conductive hearing loss, and tympanoplasty is performed to restore the integrity of the tympanic membrane and improve hearing. Platelet-rich plasma (PRP) contains growth factors that may enhance tissue healing and graft integration; however, its clinical efficacy as an adjunct to conventional underlay fascial tympanoplasty remains uncertain. This study evaluates the efficacy of PRP as an adjunct to underlay fascial tympanoplasty in patients with chronic tympanic membrane perforation. Thirty patients were randomized equally into two groups: one underwent conventional underlay tympanoplasty using temporalis fascia alone, while the other received the same procedure augmented with PRP. The primary outcome was complete tympanic membrane closure at 3 months postoperatively. Secondary outcomes included air-bone gap reduction, functional success rate (ABG gain >10 dB), and complications. The study was conducted at Capital University Hospital (Badr Hospital), Egypt, from April 2024 to December 2024.
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 19/08/2026 The right email address for the ethics committee has be provided TRUE, Research Ethics Committe REC for Human and Animal Research at the Faculty of Medicine Helwvan University, Helwan , Cairo , 11795, Egypt, , 08 Jul 2024, +20223456789, Hanan.mina@med.helwan.edu.eg, 43884_40220_4737.pdf TRUE, Research Ethics Committe REC for Human and Animal Research at the Faculty of Medicine Helwvan University, Helwan , Cairo , 11795, Egypt, , 08 Jul 2024, +20223456789, rec_committee@med.capu.edu.eg, 43884_40220_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 18/08/2026 For writing the full name of the funding source Self funded , helwan, cairo, 11795, Egypt, Self Funded, Christina Nagah GadElsayd AbdElmaseeh , helwan, cairo, 11795, Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 26/08/2026 to add latest results overview No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 26/08/2026 to add latest results overview 43884_30989_1045.pdf