Evaluation of the use of an advanced platelet-rich fibrin (A-PRF+) membrane in children undergoing primary palatoplasty-- a prospective randomized clinical pilot-study.

The aim of this study was to evaluate whether an A-PRF + membrane can lower the fistula rate in patients undergoing primary palatoplasty. A total of 20 children were included: 10 were randomized and included in the platelet-rich fibrin (PRF) group, and 10 were assigned to the control group. Before two-flap palatoplasty was performed, the cleft's width was measured. The patients in the PRF group underwent an intraoperative collection of 5 ml venous blood, which was centrifugated and pressed onto an A-PRF + membrane. Subsequently, the membrane was placed between the oral and nasal mucosal layers. The control group underwent the same procedure without the addition of A-PRF+. The need for transfusions or postoperative intensive care was registered. All children were followed up at 10 days, 1, 2, 3, and 6 months, and after more than 6 months and the occurrence of fistulae and need for a second palatal operation was then evaluated. After more than six months postoperatively, only two fistulae (10%) remained and had to undergo secondary palatoplasty (p = 1.00). Moreover, the blood transfusion rate did not differ significantly (p = 1.00). A-PRF + might be beneficial in cleft closure, but further randomized studies with larger patient cohort are needed.