| CTRI Number |
CTRI/2024/07/071184 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The efficacy of using Platelet-Rich Fibrin (PRF) with conventional technique of Cleft Palate Repair |
|
Scientific Title of Study
|
A Randomized Controlled clinical Trial comparing the efficacy of using Platelet-Rich Fibrin (PRF) with conventional technique of Cleft Palate Repair |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soujanya M |
| Designation |
Senior Resident |
| Affiliation |
J. N. Medical College KLE Academy of Higher Education and Research Belgaum |
| Address |
Department of Plastic and Reconstructive Surgery, J.N Medical College. KLE Academy of Higher Education and Research,
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
mahadevsoujanya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Power |
| Designation |
Professor and HOD |
| Affiliation |
J. N. Medical College KLE Academy of Higher Education and Research Belgaum |
| Address |
Department of Plastic and Reconstructive Surgery.
J.N Medical College. KLE Academy of Higher Education and Research.
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
kleplasticsurgery@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soujanya M |
| Designation |
Senior Resident |
| Affiliation |
J. N. Medical College KLE Academy of Higher Education and Research Belgaum |
| Address |
Department of Plastic and Reconstructive Surgery, J.N Medical College, KLE Academy of Higher Education and Research.
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
mahadevsoujanya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Plastic and Reconstructive Surgery. J. N Medical College, Belagavi, Karnataka India 590010 |
|
|
Primary Sponsor
|
| Name |
Kahers Jawaharlal Nehru Medical College |
| Address |
Department of Plastic & Reconstructive Surgery
J. N. Medical College
KLE Academy of Higher Education & Research Belgaum -10
|
| Type of Sponsor |
Private 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 |
| Dr Rajesh Powar |
KLE Prabhakar Kore hospital, Belgaum |
Department of Plastic and Reconstructive Surgery, J.N Medical College, KLE Academy of Higher Education and Research, Nehru Nagar, Belgaum 5900010
Belgaum
KARNATAKA |
08312473777
kleplasticsurgery@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q359||Cleft palate, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Platelet Rich Fibrin ( no PRF) |
Patients enrolled into the "no PRF" group are provided the conventional care as per the standard procedures. The patient is prepared and taken for surgery. The surgery is performed as per conventional procedure. The typical duration for this surgery is 2 to 3 hours. PRF is not prepared and not applied on the surgical wound. Standard conventional post surgical care is provided and discharged. Patient follow up after 3 months |
| Intervention |
Platelet Rich Fibrin ( PRF ) |
The patient is prepared and taken for surgery. The surgery is performed as per conventional procedure. The typical duration for this surgery is 2 to 3 hours. In the operating, in parallel to the surgery, PRF is prepared from the patients own blood sample as per procedure.
PRF is prepared by centrifuging patients own blood sample, for 10 minutes. Immediately after suturing, the prepared PRF is applied over wet gauze and fixed onto the surgical wound. Applying the PRF on the surgical wound takes les than 5 minutes. Standard, conventional post surgical care is provided and discharged. patient follow up after 3 months |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
3.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted for cleft palate repair under Department of Plastic & Reconstructive Surgery in KLE Prabhakar Kore hospital, Belgaum fulfilling the following criteria:
1 Patients with non-syndromic cleft palate.
2 Patient Age: 1 to 3 years
3 Consent signed for application of PRF and follow up examinations for 6 months post initial treatment.
|
|
| ExclusionCriteria |
| Details |
1 Lack of consent
2 Patients with syndromic cleft disease or bleeding disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients under PRF treatment group show statistically significant improved wound healing in comparison with non PRF patients group . |
Wound healing status reviewed until discharge : 1 week.
Palatal Fistula and other issues reviewed : 3 and/or 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of patients in PRF group developing palatal fistula is significantly less than the Number of patients without PRF developing palatal fistula |
review conducted 6 months post discharge |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/08/2024 |
| Date of Study Completion (India) |
04/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
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
Modification(s)
|
The purpose of this study is to compare the effectiveness of using Platelet-Rich Fibrin (PRF) with conventional technique in cleft palate repair, by conducting a Randomized Controlled clinical Trial. We hope to learn whether using PRF can improve the healing of the surgical wound and ultimately reduce the occurrence of palatal fistula.1.1 Source of Data: All cases of cleft palate in Department of plastic and reconstructive surgery at KLE’s Prabhakar Kore hospital, Belgaum. 1.2 Study Design: Randomized Controlled Trial Primary Purpose : Treatment Allocation : Randomized Interventional model : Parallel assignment Masking : Single Test/PRF Study group Pt: patients treated with PRF post-surgery; No intervention Control group Pc : patients not treated with PRF post-surgery. Hypothesis 1: Patients under PRF treatment in Pt group show statistically significant improved wound healing in comparison with non PRF patients in group Pc . Hypothesis 2: Number of patients in Pt developing palatal fistula is significantly less than the Number of patients in Pc developing palatal fistula. Null hypothesis: No statistically significant difference between the group Pt and group Pc, on the following parameters : · Wound healing : complications and duration Palatal fistula ( after 6 months ) : occurred / not occurred |