Can a blood-derived patch strengthen cleft palate repair?

NCT ID NCT07752849

First seen Aug 07, 2026 ยท 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 โ€” 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Al_ Thawra General Hospital Authority

    RECRUITING

    Sanaa, Yemen

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