| CTRI Number |
CTRI/2025/03/082939 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the role of a blood product named platelet rich fibrin(PRF) derived from blood of patient himself in reducing complications of hypospadias surgery |
|
Scientific Title of Study
|
Post operative complication rates in children undergoing hypospadias repair with or without Platelet Rich Fibrin - A randomized controlled study |
| 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 Satish Kumar Aggarwal |
| Designation |
Chairperson and senior consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Paediatric surgery department office, 7th floor E block, sir ganga ram hospital, New Delhi.
New Delhi
DELHI
110060
India |
| Phone |
9868334600 |
| Fax |
|
| Email |
satish.childurology@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satish Kumar Aggarwal |
| Designation |
Chairperson and senior consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Paediatric surgery department office, 7th floor E block, sir ganga ram hospital, New Delhi.
New Delhi
DELHI
110060
India |
| Phone |
9868334600 |
| Fax |
|
| Email |
satish.childurology@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hardik Vallabhbhai Parmar |
| Designation |
DrNB trainee |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Paediatric surgery department office, 7th floor E block, sir ganga ram hospital, New Delhi.
New Delhi
DELHI
110060
India |
| Phone |
9727790766 |
| Fax |
|
| Email |
parmarh905@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Ganga Ram hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Sir Ganga Ram Hospital |
| Address |
Sir Ganga Ram Hospital, Rejinder Nagar, New Delhi, Delhi- 110060 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Satish Kumar Aggarwal |
Sir Ganga Ram Hospital |
Pediatric surgery department, 7th floor, E-Block.
New Delhi
DELHI |
9868334600
satish.childurology@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Sir Ganga Ram Hospoital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q549||Hypospadias, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
Platelet Rich Fibrin (PRF) |
Platelet Rich Fibrin is a new generation platelet concentrate which is derived after centrifuging blood of the patient himself. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Male |
| Details |
Boys in the age group of 1-18 years with hypospadias suitable for repair |
|
| ExclusionCriteria |
| Details |
1) More than one previous failed surgeries of hypospadias. 2) Hypospadias with disorder of sexual differentiation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| complications-1) Urethro-cutaneous fistula 2) Wound dehiscence 3) Skin necrosis |
At- 1 week, 2 weeks, 3 weeks, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2025 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [parmarh905@gmail.com].
- For how long will this data be available start date provided 01-04-2029 and end date provided 01-04-2049?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
To compare complication rates in two groups of children undergoing hypospadias repair. One group with the use of Platelet Rich Fibrin and another group without the use of Platelet Rich Fibrin. |