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CTRI Number  CTRI/2024/07/069879 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) [Autologous Platelet Gel]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of Blood Products to Improve Surgery in Children 
Scientific Title of Study   Use of Platelet Rich Plasma Gel in preventing healing complications of Tubularised Incised Plate Urethroplasty in Children with distal and mid-penile hypospadias  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shreyas Dudhani 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, Patna 
Address  Department of Pediatric Surgery 2B, 2nd Floor, OPD Building All India Institute of Medical Sciences, Phulwari-sharif, Patna, Bihar

Patna
BIHAR
801507
India 
Phone  7259614064  
Fax    
Email  shreyas.dudhani45@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Amit Kumar Sinha 
Designation  Additional Professor 
Affiliation  AIIMS Patna 
Address  Department of Pediatric Surgery 2B, 2nd Floor, OPD Building All India Institute of Medical Sciences, Phulwari-sharif, Patna, Bihar

Patna
BIHAR
801507
India 
Phone    
Fax    
Email  dr_amits@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Shreyas Dudhani 
Designation  Senior Resident 
Affiliation  AIIMS Patna 
Address  Department of Pediatric Surgery 2B, 2nd Floor, OPD Building All India Institute of Medical Sciences, Phulwari-sharif, Patna, Bihar


BIHAR
801507
India 
Phone  7259614064  
Fax    
Email  shreyas.dudhani45@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Phulwari-sharif, Patna, Bihar, India - 801507 
 
Primary Sponsor  
Name  Shreyas Dudhani 
Address  All India Institute of Medical Sciences, Phulwari-sharif, Patna, Bihar, India - 801507 
Type of Sponsor  Other [Self] 
 
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 
Dr Shreyas Dudhani  All India Institute of Medical Sciences  Department of Pediatric Surgery 2B, 2nd Floor, OPD Building
Patna
BIHAR 		 7259614064

shreyas.dudhani45@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Patna, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q541||Hypospadias, penile,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Autologous Platelet Rich Plasma Gel  Use of Autologous (Patients Own) Blood to prepare a platelet gel and use it as a protective layer over urethroplasty in hypospadias patients which will remain insitu till it is degraded naturally over 90 days by the body 
Comparator Agent  Standard Tubularised Incised Plate Urethroplasty  Performing a standard Tubularised Incised Plate Urethroplasty in Hypospadias Patients 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  14.00 Year(s)
Gender  Male 
Details  Primary Hypospadias
Distal and Mid Penile Hypospadias
 
 
ExclusionCriteria 
Details  Redo Surgery
Associated with Undescended testis, major system anomaly
Bleeding Disorder, Thrombocytopenia
All Other Varieties of Hypospadias (Severe)
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Post Operative Urethrocutaneous Fistula formation  1 and 3 months post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Post Operative Wound Infection,
Post Operative Glans Dehiscence,
Post Operative Meatal Stenosis,
HOSE Score
 		 1 and 3 months after surgery 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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   Phase 2 
Date of First Enrollment (India)   15/07/2024 
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="1"
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
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shreyas.dudhani45@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Hypospadias is a fairly common congenital disorder of the male external genitalia. It leads to an abnormally positioned urethral meatus on the underside of the penis and is associated with downward bending of penis and deficient foreskin. It is surgically repaired in multiple ways with each repair having its own complications. Complete or partial failure of the repair can occur in the form of urethrocutaneous fistula, glans dehiscence, urethral or meatal stenosis and stricture urethra. These complications can often be prevented with a good layered closure of the urethra which ensures adequate blood supply and healing of tissue.
Platelet rich plasma gel is a platelet concentrate formed by centrifugation of whole blood. It has been shown to promote wound healing. Hence it would be ideal to use something that improves vascularity and tissue growth.
We expect a decreased proportion of complications (urethrocutaneous fistula) in the group in which PRP gel is used. The post operative HOSE (Hypospadias Objective Scoring Evaluation) is expected to be better in the study group. Patients with fewer complications will require fewer hospital visits and fewer surgeries
 
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