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Can a Blood-Derived patch reduce complications in penile surgery?

NCT ID NCT07757828

Disease control Sponsor: Ain Shams University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial tests whether applying a platelet-rich fibrin (PRF) membrane during hypospadias repair surgery improves healing and reduces complications like fistulas. PRF is made from the patient's own blood and is thought to support tissue repair. The study will include 80 boys with primary distal or mid-penile hypospadias undergoing standard repair. Half will receive the standard surgery plus PRF, and half will receive standard surgery alone, with outcomes compared.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Platelet-rich fibrin (PRF) applied during hypospadias repair surgery
What this could lead to
If effective, PRF could become a simple, safe addition to hypospadias surgery, reducing fistulas and improving healing.
What could go wrong
This is a small, early-stage trial. PRF may not significantly reduce complications, and results may not apply to all hypospadias cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 18 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosed with primary distal or mid-penile hypospadias. * Eligible for first-time (primary) surgical repair using the TIP (Tubularized Incised Plate) technique. Exclusion Criteria: * previous hypospadias surgery. * Associated severe chordee requiring staged repair or patient with crippled hypospadias. * Children with systemic diseases that may impair wound healing (e.g., diabetes, immunodeficiency, malnutrition). * Presence of bleeding or coagulation disorders. * Medically Unfit for surgery.

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Conditions

The condition(s) this trial relates to.

hypospadias

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypospadias

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ain Shams University

    Cairo, Abbasia, 11517, Egypt

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