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Updated: Apr 16, 2026
Characterization of Leukocyte-platelet Rich Fibrin, A Novel Biomaterial
Published on: September 29, 2015
An RCT Evaluating the Efficacy of Using Platelet-Rich Fibrin (PRF) with Conventional Technique of Cleft Palate Repair
1Department of Plastic and Reconstructive Surgery, Kaher's Jawaharlal Nehru Medical College & KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre, Belagavi, Karnataka, India.
Insights
Platelet-rich fibrin (PRF) shows promise in reducing palatal fistula after cleft palate repair. While PRF application resulted in zero fistulas, further research is needed to confirm its effectiveness due to a small sample size.
Area of Science:
- Regenerative Medicine
- Oral and Maxillofacial Surgery
- Pediatric Surgery
Background:
- Cleft palate (CP) repair is complex, with palatal fistula formation being a significant postoperative complication.
- Platelet-rich fibrin (PRF) is a biomaterial gaining attention for its potential in tissue regeneration and wound healing.
Purpose of the Study:
- To evaluate the efficacy of platelet-rich fibrin (PRF) as an adjunct in cleft palate (CP) repair.
- To determine if PRF reduces the incidence of postoperative palatal fistula formation.
Main Methods:
- A randomized controlled trial (RCT) with 100 non-syndromic CP patients aged 1-3 years.
- Participants were randomized 1:1 to receive standard CP repair with PRF application (intervention) or standard CP repair alone (control).
- PRF was prepared using Choukroun's method and applied during surgery; outcomes included palatal fistula, wound dehiscence, and bleeding.
Main Results:
- No cases of wound dehiscence or postoperative bleeding were observed in either the PRF or control groups.
- Palatal fistula occurred in 6% of patients in the control group (non-PRF).
- No palatal fistulas were observed in the PRF group, although the overall study was limited by a small number of fistula occurrences.
Conclusions:
- Platelet-rich fibrin (PRF) appears to be a safe and potentially beneficial adjunct in cleft palate repair.
- The study suggests PRF may reduce palatal fistula rates, but the findings are inconclusive due to the low incidence of fistulas.
- Larger studies are warranted to statistically substantiate the efficacy of PRF in minimizing palatal fistula formation.
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.
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