Ford Henri R, Jones Peter, Gaines Barbara, Reblock Kimberly, Simpkins Dorella L
Department of Surgery, Division of Pediatric Surgery, University of Southern California Keck School of Medicine, Los Angeles, California 90027, USA.
Surg Infect (Larchmt). 2005 Fall;6(3):313-21. doi: 10.1089/sur.2005.6.313.
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.
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.
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.
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.
含三氯生的聚乙醇酸910涂层缝线是最近研发出来的，目的是赋予母体缝线（聚乙醇酸910涂层缝线）针对引起手术部位感染（SSI）的最常见微生物的抗菌活性。由于此类改变可能会改变缝线的物理特性，本研究旨在比较含三氯生的聚乙醇酸910涂层缝线与传统聚乙醇酸910涂层缝线在接受各种普通外科手术的儿科患者中的术中操作和伤口愈合特点。
这是一项前瞻性、随机、对照、开放标签、比较性单中心研究。接受各种外科手术的儿科患者（年龄1至18岁）按2:1的比例随机分为两组，分别接受含三氯生的聚乙醇酸910涂层缝线或聚乙醇酸910涂层缝线治疗。主要终点是外科医生对含三氯生的聚乙醇酸910涂层缝线与不含三氯生的传统聚乙醇酸910涂层缝线的总体术中操作评估。次要终点包括特定的术中缝线操作指标和伤口愈合评估。缝线操作指标包括：（1）穿过组织的难易程度；（2）初次打结的牢固程度；（3）打结收紧的顺畅程度；（4）结的牢固性；（5）手术操作；（6）手术手感；（7）弹性记忆；（8）缝线磨损情况。伤口愈合评估包括以下方面：愈合进程、感染、水肿、红斑、皮肤温度、血清肿、缝线窦道和疼痛。记录不良事件。
两种缝线的术中操作评分均良好且无显著差异，不过含三氯生的聚乙醇酸910涂层缝线获得更多“优秀”评分（71%对59%）。除术后第1天的疼痛外，两种缝线的伤口愈合特点相当。接受含三氯生的聚乙醇酸910缝线治疗的患者在第1天报告疼痛的人数明显少于接受另一种缝线治疗的患者（68%对89%，p = 0.01）。不良事件的总体发生率为18%；均与器械无关。
在接受普通外科手术的儿科患者中，含三氯生的聚乙醇酸910涂层缝线的表现与传统聚乙醇酸910涂层缝线相当或更优。接受含三氯生的聚乙醇酸910涂层缝线治疗的患者术后疼痛发生率明显低于传统缝线。我们推测，含三氯生的聚乙醇酸910缝线通过抑制缝线的细菌定植，减轻了可能是“亚临床”感染指标的疼痛。含三氯生的聚乙醇酸910涂层缝线可能是发生SSI风险增加患者的一种有用替代选择。
