Palatoplasty techniques using PRF and antibiotic-loaded PRF in cleft palate
Official title: A Prospective Randomized Clinical Trial Comparing Standard Palatoplasty Alone, Standard Palatoplasty With Platelet-Rich Fibrin (PRF), and Standard Palatoplasty With Gentamicin-Loaded PRF for Unilateral and Bilateral Complete and Incomplete Cleft Palate Cases
Run by Al-Thawra Modern General Hospital · NCT07752849 · Data updated 2026-11-12
This trial tests whether adding autologous PRF or gentamicin-loaded PRF to primary palatoplasty helps kids with unilateral or bilateral cleft palate heal better and have fewer fistulas than standard surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Months to 18 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Al-Thawra Modern General Hospital Academic / other |
| Locations | 1 site (Sanaa) |
| Status | Recruiting |
| Started | August 1, 2026 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | August 7, 2026 |
| Trial ID | NCT07752849 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children and adolescents with non-syndromic unilateral or bilateral cleft palate (complete or incomplete) who are scheduled for primary palatoplasty and have parental consent.
✕Probably not a fit
Patients with syndromic clefts, prior palatal surgery, significant bleeding disorders, active systemic infection, or other contraindications to surgery may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective randomized trial will enroll 90 pediatric and adolescent patients with unilateral or bilateral cleft palate, both complete and incomplete, and assign them to one of three treatment arms: standard palatoplasty, palatoplasty with standard PRF, or palatoplasty with gentamicin-loaded PRF. The study will compare mucosal healing scores, wound dehiscence, and the rate of postoperative oronasal fistula formation to determine if PRF with or without gentamicin improves soft-tissue healing and reduces surgical breakdown. Autologous PRF is used as a regenerative adjunct, with the antibiotic-loaded variant intended to provide local antimicrobial effects. Primary outcomes focus on healing quality and complication rates following the procedure.
Why it matters
Potential benefit: If successful, the approach could improve healing after cleft palate repair and reduce fistula formation, potentially decreasing the need for additional surgeries.
How similar studies have gone: Previous work on PRF in palatoplasty is emerging; this trial extends to gentamicin-loaded PRF to address infection risk, with ongoing evaluation of efficacy.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Al_ Thawra General Hospital Authority
Sanaa, Yemen Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.