A Prospective, Multi-Center, Randomized Controlled Study to Evaluate the Efficacy and Safety of Two Absorbable Barbed...

This study aimed to evaluate the safety and effectiveness of two types of absorbable barbed sutures, STRATAFIX^TM Spiral PDS^TM Plus and STRATAFIX^TM Spiral MONOCRYL^TM Plus, compared with traditional sutures made of the same material in the suturing of thyroid surgery incision.

This study was a multicenter, prospective, evaluator-blinded, three-arm, non-inferiority, randomized controlled design study with a planned enrollment of 501 patients undergoing open thyroid surgery. Subjects were randomized to Spiral PDS Plus group, Spiral MONOCRYL Plus group, or the control group, according to the allocation ratio of 1:1:1. The primary endpoint was the success rate of subjects achieving grade A healing of surgical incisions 5-7 days after surgery.

A total of 500 subjects were randomized in this study. The PP analysis was considered the primary analysis, while the FAS analysis was considered supportive. In the PPset, which included 154 subjects in Spiral PDS Plus group, 157 subjects in Spiral MONOCRYL Plus group, and 156 subjects in the control group, the grade A wound healing success rates were 99.4%, 98.7%, and 99.4%, respectively. The differences [Wald 95% CI] in success percentage between the two investigation groups and the control group were -0.01% [-1.79%, 1.77%] and -0.63% [-2.79%, 1.52%], respectively. Both Spiral PDS Plus and Spiral MONOCRYL Plus were found to be non-inferior to control in achieving Grade A healing of surgical incision (0.05 margin, p < 0.0001 for both).

This study demonstrated the short-term safety and efficacy outcomes of using STRATAFIX^TM Spiral PDS^TM Plus and STRATAFIX^TM Spiral MONOCRYL^TM Plus sutures in the suturing of thyroid surgery incision, with acceptable risk-benefit.