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

A randomized controlled trial of platelet rich fibrin PRF versus dartos flap use in TIP urethroplasty in anterior hypospadias A pilot study

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098319

Enrollment

Registered

2025-12-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N998- Other intraoperative and postprocedural complications and disorders of genitourinary system

Interventions

Intervention1: 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 hypospad

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To compare the incidence of urethrocutaneous fistula between both the groupsTimepoint: 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

Measure	Time frame
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.Timepoint: These outcomes will be assessed in postoperative period -at discharge,at 1 month follow up & at 2 months & at 3 months follow up.	—

Countries

India

Contacts

Public ContactDr Abhishek Dhiman

Post Graduate Institute of Medical Education and Research

drmuneerabas@gmail.com9796452773

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026