An RCT Evaluating the Efficacy of Using Platelet-Rich Fibrin (PRF) with Conventional Technique of Cleft Palate Repair.

Abstract

ObjectiveTo evaluate the effectiveness of platelet-rich fibrin (PRF) in the repair of cleft palate (CP), with a primary goal of reducing the occurrence of postoperative palatal fistula formation.DesignAn RCT was conducted with a 1:1 allocation ratio.SettingSingle-center study conducted in the Department of Plastic & Reconstructive Surgery at a tertiary care center.Participants100 CP repair patients enrolled based on the following inclusion criteria: Non-syndromic CPAge between 1 and 3 yearsInformed consent.InterventionsParticipants were randomized using a computer-generated sequence into 2 groups (n = 50 each). The intervention group received PRF, prepared by Choukroun's method from a 5 to 7 mL blood sample, and applied during surgery. The control group underwent standard CP repair without PRF. Both groups received identical pre & postoperative care.Main OutcomesPalatal-fistula formation, wound dehiscence, and postoperative bleeding were assessed.No cases of wound dehiscence or postoperative bleeding were observed in either group.Palatal fistula occurred in 3 patients (6%) in the control group (non-PRF), while no cases were observed in the PRF group.ResultsThree palatal fistula cases were observed (3%; n = 100), 0% in the PRF group (n = 50), and 6% in the non-PRF group (n = 50).ConclusionsWhile PRF appears to be safe, biologically promising, and cost-effective adjunct in CP repair; the study was inconclusive as the small number of fistula occurrence limited ability to statistically substantiate its efficacy in reducing palatal fistula.