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CTRI Number  CTRI/2025/12/098319 [Registered on: 02/12/2025] Trial Registered Prospectively
Last Modified On: 01/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the benefits of using PRF (Platelet Rich Fibrin) as protective layer in Snodgrass’s urethroplasty in patients with Hypospadias and to compare it with conventionally used Dartos flap 
Scientific Title of Study   A randomized controlled trial of platelet rich fibrin PRF versus dartos flap use in TIP urethroplasty in anterior hypospadias A pilot study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhishek Dhiman 
Designation  Junior Resident, Department of General Surgery , PGIMER 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  107, Married Doctor’s hostel, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8219268144  
Fax    
Email  dhiman.abhishek9293@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Muneer Abas Malik 
Designation  Additional Professor, Department of Pediatrics Surgery, PGIMER, Chandigarh 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  5th floor (faculty offices) , Advanced Pediatrics centre, PGIMER, Sector 12, Chandigarh.

Chandigarh
CHANDIGARH
160012
India 
Phone  9796452773  
Fax    
Email  drmuneerabas@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhishek Dhiman 
Designation  Junior Resident, Department of General Surgery, PGIMER 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Room no 107, Married doctor’s hostel , PGIMER, Sector-12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8219268144  
Fax    
Email  dhiman.abhishek9293@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatrics Surgery, 6th floor D block , Advanced Pediatrics Centre, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh, India , Pin Code- 160012 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research PGIMER Chandigarh 
Address  Department of Pediatrics Surgery, 6th floor D block , Advanced Pediatrics Centre, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh, India , Pin Code- 160012 
Type of Sponsor  Research institution and hospital 
 
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 Abhishek Dhiman  Postgraduate Institute of Medical Education and Research (PGIMER  Department of Pediatrics Surgery 6th floor D Block ,Advanced Pediatrics Centre, PGIMER, Sector 12, Chandigarh, India . Pin code- 160012
Chandigarh
CHANDIGARH 
8219268144

dhiman.abhishek9293@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER Chandigarh Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dartos flap  Use of traditional dartos flap coverage as 2nd layer over Snodgrass TIP (tubularized incised plate) urethroplasty for middle and distal hypospadias. The procedure /surgery Snodgrass’s TIP urethroplasty for every patient will take approximately 1-2 hours. Patients will be then be followed monthly for a period of 3 months (at 1 month, 2 months and 3 months respectively) for the results. So in total it will taken total 3 months for intervention and results. 
Intervention  Platelet rich fibrin membrane  Use of platelet rich fibrin membrane as 2nd layer of coverage over Snodgrass TIP ( tubularised incised plate) urethroplasty for distal and middle hypospadias. Patient blood sample will be taken and in about 20 minutes PRF (platelet rich fibrin) membrane will be prepared from it. The procedure /surgery Snodgrass’s TIP urethroplasty for every patient will take approximately 1-2 hours. Patients will be then be followed monthly for a period of 3 months (at 1 month, 2 months and 3 months respectively) for the results. So in total it will taken total 3 months for intervention and results. 
 
Inclusion Criteria  
Age From  18.00 Month(s)
Age To  12.00 Year(s)
Gender  Male 
Details  All primary cases between 18 months to 12 years of age diagnosed with distal and mid-penile hypospadias with minimal/no chordee and suitable for Snodgrass Tubularized incised plate urethroplasty.
 
 
ExclusionCriteria 
Details  Parents/Guardians not giving a valid consent for the study.
Patients with severe chordee
Patients who were lost to follow up after surgery
Patients on anticoagulant therapy
Thrombocytopenia with counts less than 60,000/mm3
Immunocompromised patients/ uncontrolled diabetes/ chronic severe illness.
Patients not fit for anesthsia.
Patient in any neurological diseased state.
Patients having proximal penile hypospadias
Patients requiring 2-stage repair of hypospadias.
Previously operated cases
Patients with undescended testes 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of urethrocutaneous fistula between both the groups  To compare the occurrence of urethrocutaneous fistula formation rate between the two groups which will be assessed in postoperative period -at discharge,at 1 month follow up and at 2 months and at 3 months follow up. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess post operative rate of postop pain , surgical site infections( using Southampton scale) , length of hospital stay, occurrence of mental stenosis & strictures between two groups.   These outcomes will be assessed in postoperative period -at discharge,at 1 month follow up & at 2 months & at 3 months follow up. 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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 3/ Phase 4 
Date of First Enrollment (India)   15/12/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  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 (Others) -  Through email

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This a prospective randomized controlled pilot study in which we will be focusing on the outcomes and benefits in using autologous Platelet rich Fibrin membrane (PRF)  as 2nd coverage layer in Snodgrass Tubularized Incised plate (TIP) urethroplasty. All primary cases between 18 months to 12 years of age diagnosed with distal and mid-penile hypospadias with minimal/no chordee will be included in the study. We have a total sample size of 42 patients which will be divided into two groups after randomization. Group A  will be provided with autologous PRF membrane  and group B will be provided with traditionally used Dartos flap as 2nd coverage layer in Snodgrass TIP urethroplasty.  There are high complication rates with traditional techniques being used like dartos flaps/tunica vaginalis flaps with urethrocutaneous fistulas being one the most common. Platelet rich fibrin membrane is being used because of its  better tolerance, immunogenic properties,  lesser /minimal chances of allergic reaction and its promising results in promoting natural wound healing.

PRF membrane will be made by using 10-20ml of patients venous blood collected in a blood bag having CPDA (Citrate-Phosphate-Dextrose and Adenine) as anticoagulants. 
This whole blood will then be transferred into a sterile tube using a blood transfusion set.  PRF will be prepared with the double spin platelet pellet method. Using a tabletop centrifuge , the initial spin will be done at 1300rpm for 15 mins. The supernatant plasma (which has all the platelets and a few WBCs) will be pipetted out and transferred to another sterile tube. Inj. calcium gluconate will be diluted with normal saline (1:7) to make calcium content (M/40) inside the biosafety cabinet, under aseptic conditions. This calcium solution will be added before second step of centrifugation. It causes formation of autogenous thrombin but prevents activation of platelets. It will then be subjected to a second spin at 2300 rpm (885g) for 5 min. During 2nd step of centrifugation, dense fibrin network will be formed (Fig 1). Intact platelets will be trapped in this matrix. Fibrin acts as scaffold and trapped platelets slowly release growth factors GFs over a period of 7 days. Thereafter the final step will be securing the fixation by using a few 6–0 interrupted polyglactin/Vicryl sutures. 
Postoperative course and outcomes will be compared among both groups in the subsequent follow up at POD 3 and at the end of 1st,2nd and 3rd month. Our main objective shall remain the comparison in the urethrocutaneous fistula rate between the two groups as we hypothesize that use of Platelet rich fibrin membrane has a low urethrocutaneous fistula rate in comparison with traditional dartos flap when they are used as coverage layer over urethroplasty.

 
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