| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- Who will be able to view these files?
Response - Anyone
- 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 (Others) - Through email
- 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.
- 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.
|