Evaluating Platelet-Rich Fibrin and Gentamicin-Loaded PRF as Additions to Standard Palatoplasty Surgery in Children and Teens with Cleft Palate

What this Trial Is About

Researchers are evaluating the effectiveness of two biological treatments, autologous Platelet-Rich Fibrin PRF and Gentamicin-Loaded PRF, as supportive therapies in primary palatoplasty surgery for children and adolescents with various types of cleft palate. The study aims to compare these treatments against the standard palatoplasty procedure to see if they improve tissue healing and reduce the chance of surgical complications such as wound breakdown and oronasal fistulas. Participants will be randomly assigned to one of three groups standard palatoplasty without any biological adjuncts, palatoplasty with autologous PRF, or palatoplasty with gentamicin-loaded PRF. The gentamicin-loaded PRF is studied for its potential antimicrobial properties in addition to supporting healing. Each participant will undergo their assigned surgical treatment as part of the trial. During the study, researchers will monitor wound healing and surgical outcomes at specific time points wound dehiscence rates and healing scores will be assessed at 7, 14, and 30 days after surgery, while the rate of palatal fistula formation will be evaluated at 3 months postoperatively. The trial includes pediatric and adolescent patients aged from 3 months to 18 years and will last until December 2028. Consent from parents or legal guardians is required for participation.

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