Pearls and Pitfalls in Usage of Plasma-Rich Platelet Graft Versus Dartos Flap in Distal Penile Hypospadias Repair

NCT06808139 | Not Yet Recruiting DMC

• 1 other identifier: PRPgraft/DartosflapHypospadias
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hypospadias is the most common congenital anomaly of penis. It is the second most common genital birth defect in boys after cryptorchidism The reinforcement of hypospadias repair with an intermediate layer is believed to reduce the incidence of postoperative complications such as uretherocautanous fistula. Hypospadias is classified by the location of the abnormal urethral meatus into distal penile (glandular ,subcoronal and distal penile), mid penile and proximal penile hypospadias Indeed, uretherocautanous fistula is most common complication after urethroplasty, with introduction of a protective layer between the neourethra and the covering skin strongly reduces fistulas occurrence and the overall complication the aim of the study To evaluate and to compare the use of PRP covering layer and dartos fascia flap layer in regard to complication rates in hypospadias repair

Conditions

Penile Hypospadias

Keywords

Plasma-Rich Platelet Graft; Dartos Flap

Outcome Measures

Primary Outcomes (1)

• incidence of occurrence of uretherocutanous fistula

  occurrence of conection between urthera and skin

  6 month

Study Arms (2)

Group A

ACTIVE COMPARATOR

Plasma-Rich Platelet Graft

Procedure: Plasma-Rich Platelet Graft

Group B

ACTIVE COMPARATOR

Dartos Flap

Procedure: Dartos Flap

Interventions

Plasma-Rich Platelet Graft PROCEDURE

The clot was extracted from the tube, separated from red blood cells, and gently compressed between two surgical swabs to obtain a soft and resistant membrane. The Snodgrass technique was carried out for all patients, with a suitable size catheter (8-12-Fr), repair was carried out by a continuous layer of polyglycolic suture (Vicryl) size 6/0, covered by an interrupted second layer. In group A, after finishing the Snodgrass TIPU, a PRP sheet coverage was applied over urethroplasty and secured by Vicryl 7/0, and finally the skin sutured directly without any covering layers

Group A

Dartos Flap PROCEDURE

preputial dartos flap will be used

Group B

Eligibility Criteria

• Age: 6 Months+
• Gender Eligibility Details: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>6 months
• Distal penile hypospadias
• Denovo hypospadias

You may not qualify if:

• Recurrent hypospadias -Mid and proximal penile hypospadias

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ahmed ali amen diab, residant doctor

CONTACT

+201023222678; Ahmed.16266237@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 5, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-01