An interventional study of Standard palatoplasty ( control) and Platelet _ Rich Fibrin ( PRF) in Cleft Palate, Unilateral Cleft Palate and Bilateral Cleft Palate, sponsored by Al-Thawra Modern General Hospital. Recruiting at 1 site in Yemen. Open to participants aged 3 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Al-Thawra Modern General Hospital · Not applicable, Interventional, and Treatment
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
123 studies on the registry are indexed under Cleft Palate; 35 are open to participants now.
This study's planned enrollment of 90 is above the median of 44 across 77 interventional studies indexed under Cleft Palate.
Browse Cleft Palate studies →This is the only study on the registry with Al-Thawra Modern General Hospital as lead sponsor.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Conventional palatoplasty without biological adjuncts
Procedure: Standard palatoplasty ( control)
Conventional palatoplasty augmented PRF
Procedure: Platelet _ Rich Fibrin ( PRF)
Conventional palatoplasty augmented with gentamicine - loaded PRF
Combination Product: gentamicin_ loaded PRF
Conventional palatoplasty performed without biological adjuncts
Conventional palatoplasty augmented with autologous PRF matrix
Conventional palatoplasty augmented with gentamicin \_ loaded PRF matrix
Wound dehiscence rate
Assessed using Wound Dehiscence Severity Score (WDSS) ranging from 0 (Intact, complete structural integrity) to 3 (Complete failure, full-thickness structural separation requiring surgical revision). Higher scores indicate worse outcomes.
Time frame: At 7 day , 14 day , and 30 day postoperatively
palatal fistula formation rate
Assessed using Oronasal Fistula Severity \& Dimension Score (OFSDS) ranging from 0 (Absent, intact palate) to 3 (Major fistula, anatomical defect \> 5 mm requiring secondary surgical closure). Higher scores indicate worse outcomes
Time frame: at 3 month postoperatively
wound healing score
Assessed using Modified Primary Healing Scale (MPHS) ranging from 1 (Optimal Healing) to 4 (Severe Failure). Higher scores indicate worse outcomes.
Time frame: At 7 day , 14 day , and 30 day postoperatively
Started Aug 2026 (actual). Primary completion is estimated for Dec 2028, 28 months after the start.
Of 34 non-industry interventional studies with no phase under Cleft Palate, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 28 months is above that.
Counting every sponsor, half of 34 studies reached it within 18 months; a quarter within 12 and three quarters within 45.
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