Palatoplasty Techniques Using PRF and Gentamicin-Loaded PRF in Cleft Palate (NCT07752849) | Clinical Trial Compass
RecruitingNot Applicable
Palatoplasty Techniques Using PRF and Gentamicin-Loaded PRF in Cleft Palate
Yemen90 participantsStarted 2026-08-01
Plain-language summary
This prospective, randomized controlled trial evaluates the clinical efficacy of autologous Platelet-Rich Fibrin (PRF) and Gentamicin-Loaded PRF as regenerative and antimicrobial biological adjuncts in primary palatoplasty. A total of 90 pediatric and adolescent patients with unilateral and bilateral complete and incomplete cleft palates will be assigned across three parallel treatment arms: standard palatoplasty alone (control), palatoplasty augmented with standard PRF, and palatoplasty augmented with gentamicin-loaded PRF. The primary objective is to compare quantitative primary mucosal healing scores, wound dehiscence rates, and the incidence of postoperative oronasal fistula formation to determine whether local gentamicin-PRF delivery significantly improves soft-tissue healing and reduces surgical breakdown
Who can participate
Age range
3 Months – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Wound dehiscence rate
Timeframe: At 7 day , 14 day , and 30 day postoperatively
2
palatal fistula formation rate
Timeframe: at 3 month postoperatively
3
wound healing score
Timeframe: At 7 day , 14 day , and 30 day postoperatively