CClinicalTrials.gg
Not yet recruitingNCT06808139Updated Feb 5, 2025

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

An interventional study of Plasma-Rich Platelet Graft and Dartos Flap in Penile Hypospadias, sponsored by Assiut University. Not yet recruiting. Open to male participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2025-02-05.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
6 Months and older
Sex
Male
01

Study 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

Read the detailed description

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

02

Conditions studied

  • Penile Hypospadias

Browse trials for

Keywords

  • Plasma-Rich Platelet Graft
  • Dartos Flap
03

In context

Hypospadias

131 studies on the registry are indexed under Hypospadias; 34 are open to participants now.

This study's planned enrollment of 70 is close to the median of 68 across 102 interventional studies indexed under Hypospadias.

Browse Hypospadias studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Recurrent hypospadias -Mid and proximal penile hypospadias
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    Group A

    Plasma-Rich Platelet Graft

    Procedure: Plasma-Rich Platelet Graft

  • Active comparator
    Group B

    Dartos Flap

    Procedure: Dartos Flap

Interventions

  • ProcedurePlasma-Rich Platelet Graft

    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

  • ProcedureDartos Flap

    preputial dartos flap will be used

06

What researchers measure

Primary outcomes

  1. incidence of occurrence of uretherocutanous fistula

    occurrence of conection between urthera and skin

    Time frame: 6 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06808139
Lead sponsor
Assiut University
Responsible party
Ahmed ali amen diab (residant doctor, Assiut University) — Principal investigator
First posted
Feb 5, 2025
Start date
Mar 1, 2025 (estimated)
Primary completion
Mar 1, 2026 (estimated)
Completion
May 1, 2026 (estimated)
Last update
Feb 5, 2025

Study contacts

Ahmed ali amen diab, residant doctor
Contact
Ahmed.16266237@med.aun.edu.eg
+201023222678

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion