Materiovigilance of unidirectional barbed and poliglecaprone 25 nonbarbed sutures used for intraoral incision closure: An open-label prospective study

INTRODUCTION: The adverse events of sutures used for the closure of surgical incisions influence clinical outcomes. Literature on the safety profile of the application of unidirectional barbed sutures in oral and maxillofacial surgery is scarce. Hence, focused materiovigilance was done to monitor and compare the adverse events of unidirectional barbed and poliglecaprone 25 nonbarbed sutures for intraoral incision closure. METHODS: In a prospective randomized comparative study, 64 patients requiring intraoral incision closure were randomized to receive either unidirectional barbed or poliglecaprone 25 nonbarbed sutures. Postoperatively, patients were monitored for any adverse events for 15 days. Causality association of adverse events with sutures was done using the European Commission directives on safety reporting of medical devices. RESULTS: Adverse events observed with unidirectional barbed suture were suture extrusion (n = 7; 21.875%) and suture discomfort (n = 3; 9.375%). While subjects who received poliglecaprone 25 suture experienced suture discomfort (n = 6; 18.75%) and knot unraveling (n = 2; 6.25%). The number of adverse events in both groups was statistically comparable (P = 0.78). Causality assessment of adverse events was probable for suture extrusion and discomfort with nonbarbed and barbed sutures, while it was possible for knot unraveling for nonbarbed sutures. CONCLUSION: Both types of study sutures were associated with minor severity adverse events when used for the closure of intraoral surgical incisions. Suture extrusion had a probable causal association with barbed suture. Knot unraveling was possibly associated with the nonbarbed suture. Both types of suture materials were equally safe in oral and maxillofacial intraoral surgical incision closure.