The effect of collagen matrix graft on palatal fistula formation after cleft palate repair: A preliminary randomized controlled study

Abstract

Objective: The objective of this study was to compare the incidence of palatal fistula formation between cleft palate (CP) repair with collagen matrix graft and conventional repair without collagen matrix graft. Patients and Methods: This was a preliminary randomized controlled study of patients with CP who underwent primary palatoplasty (two-flap palatoplasty technique) at the Lagos University Teaching Hospital. Patients were randomly allocated to either the test group (palatoplasty with collagen graft) or the control group (palatoplasty without collagen graft). The primary outcome was palatal fistula, and secondary outcomes were wound dehiscence, surgical site inflammation, surgical site infection, and surgeon satisfaction up to 3 months postoperative (PO). Results: Ten patients were recruited, five in each group. Only one patient in the control group developed a palatal fistula at 1 month PO on the soft palate which extended to the junction of hard and soft palate at 3 months PO. Eight patients developed wound dehiscence, five in the test group and three in the control group. Surgical site inflammation persisted up to at least 7 days PO in nine patients (five in the test group and four in the control group). All persistent wound dehiscence and surgical site inflammation resolved at 3 months PO. No patient developed surgical site infection. No significant difference was seen between the study group and wound dehiscence, surgery time, and difficulty of the procedure (P > 0.05 for all associations). Conclusion: Collagen graft may have a protective effect against fistula formation without significantly increasing surgery time and difficulty. However, due to the small sample size, the study failed to draw definite conclusions. Results from this study may inform future designs of larger randomized controlled studies.