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Can a blood-derived patch strengthen cleft palate repair?

NCT ID NCT07752849

Disease control Sponsor: Al-Thawra Modern General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 07, 2026 · Last updated Aug 07, 2026

Summary

This trial compares standard cleft palate surgery alone versus surgery augmented with platelet-rich fibrin (PRF) or gentamicin-loaded PRF in 90 children and adolescents with cleft palates. The goal is to see if these biological adjuncts improve wound healing, reduce wound breakdown, and lower the risk of oronasal fistulas after surgery. Participants are randomly assigned to one of three treatment groups, and outcomes are measured using standardized healing and complication scores.

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) and gentamicin-loaded PRF used as surgical adjuncts during palatoplasty
What this could lead to
If effective, these biological dressings could reduce wound breakdown and fistulas after cleft palate repair, improving outcomes for children undergoing this surgery.
What could go wrong
This is a relatively small, early-stage trial, and the added benefit of PRF or gentamicin-PRF over standard surgery is not yet proven. There is also a risk of infection or adverse reactions to the gentamicin.

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 90 people

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

Started

Aug 2026

Expected to finish

Dec 2028

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

3 months to 18 years

Sex

Anyone

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: * Patients presenting with non-syndromic complete or incomplete unilateral or bilateral cleft palate. * Scheduled for primary palatoplasty. * Age within the specified study range. * Informed consent signed by parents or legal guardians. Exclusion Criteria: * Patients with associated syndromic clefts or major congenital anomalies. * Previous history of palatal surgery or failed prior palatoplasty. * Bleeding disorders, active systemic infections, or contraindications to surgery or general anesthesia. * Patients lost to follow-up or incomplete records.

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Conditions

The condition(s) this trial relates to.

cleft palate

As listed by the trial registrant

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

Bilateral cleft palate Cleft palate Complete cleft palat Incompelet cleft palate Unilateral cleft palate

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

  • Al_ Thawra General Hospital Authority

    RECRUITING

    Sanaa, Yemen

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