Palatoplasty Techniques Using PRF and Gentamicin-Loaded PRF in Cleft Palate

Al-Thawra Modern General Hospital90 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cleft Palate Unilateral Cleft Palate Bilateral Cleft Palate Complete Cleft Palat

Interventions

Standard palatoplasty ( control)PROCEDURE

Conventional palatoplasty performed without biological adjuncts

Platelet _ Rich Fibrin ( PRF)PROCEDURE

Conventional palatoplasty augmented with autologous PRF matrix

gentamicin_ loaded PRFCOMBINATION_PRODUCT

Conventional palatoplasty augmented with gentamicin \_ loaded PRF matrix

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.