Palatoplasty Techniques Using PRF and Gentamicin-Loaded PRF in Cleft Palate
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard palatoplasty ( control), Platelet _ Rich Fibrin ( PRF), gentamicin_ loaded PRF.
- Who it may be relevant to
- Registry conditions: Cleft Palate, Unilateral Cleft Palate, Bilateral Cleft Palate, Complete Cleft Palat. Basic parameters: 3 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Yemen
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Interventions
- Procedure Standard palatoplasty ( control)
Conventional palatoplasty performed without biological adjuncts - Procedure Platelet _ Rich Fibrin ( PRF)
Conventional palatoplasty augmented with autologous PRF matrix - Combination product gentamicin_ loaded PRF
Conventional palatoplasty augmented with gentamicin \_ loaded PRF matrix
Primary outcome measures
- Wound dehiscence rate [Time frame: At 7 day , 14 day , and 30 day postoperatively]
- palatal fistula formation rate [Time frame: at 3 month postoperatively]
- wound healing score [Time frame: At 7 day , 14 day , and 30 day postoperatively]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Yemen · 1 center
- Al_ Thawra General Hospital Authority — Sanaa
Identifiers
NCT: NCT07752849 · CLEFT_PRF_2026