Intraoperative Handling and Wound Healing: Controlled Clinical Trial Comparing Coated VICRYL® Plus Antibacterial Suture (Coated Polyglactin 910 Suture with Triclosan) with Coated VICRYL® Suture (Coated Polyglactin 910 Suture)

Abstract

BACKGROUND: Coated polyglactin 910 suture with triclosan was developed recently in order to imbue the parent suture, coated polyglactin 910, with antibacterial activity against the most common organisms that cause surgical site infections (SSI). Because such alterations could alter the physical properties of the suture, this study sought to compare the intraoperative handling and wound healing characteristics of coated polyglactin 910 suture with triclosan and traditional coated polyglactin 910 suture in pediatric patients undergoing various general surgical procedures. METHODS: This was a prospective, randomized, controlled, open-label, comparative, single-center study. Pediatric patients (age 1-18 years) undergoing various surgical procedures were randomized in a 2:1 ratio to treatment with either coated polyglactin 910 suture with triclosan or coated polyglactin 910 suture. The primary endpoint was the surgeon's assessment of the overall intraoperative handling of coated polyglactin 910 suture with triclosan and traditional coated polyglactin 910 suture without triclosan. The secondary endpoints included specific intraoperative suture handling measures and wound healing assessments. The suture handling measures were (1) ease of passage through tissue; (2) first-throw knot holding; (3) knot tie-down smoothness; (4) knot security; (5) surgical handling; (6) surgical hand; (7) memory; and (8) suture fraying. Assessment of wound healing included the following: Healing progress, infection, edema, erythema, skin temperature, seroma, suture sinus, and pain. Adverse events were recorded. RESULTS: Scores for intraoperative handling were favorable and not significantly different for both sutures, although coated polyglactin 910 suture with triclosan received more "excellent" scores (71% vs. 59%). Wound healing characteristics were comparable for both sutures except for pain on postoperative day 1. Significantly fewer patients treated with polyglactin 910 suture with triclosan reported pain on day 1 than patients who received the other suture (68% vs. 89%, p = 0.01). The overall incidence of adverse events was 18%; none was devicerelated. CONCLUSIONS: Coated polyglactin 910 suture with triclosan performed as well or better than traditional coated polyglactin 910 suture in pediatric patients undergoing general surgical procedures. The incidence of postoperative pain was significantly less in patients treated with coated polyglactin 910 suture with triclosan than the traditional suture. We speculate that polyglactin 910 suture with triclosan, by inhibiting bacterial colonization of the suture, reduced pain that can be an indicator of "subclinical" infection. Coated polyglactin 910 suture with triclosan may be a useful alternative in patients at increased risk of developing SSI.