Tae Bum Sik, Park Ju Hyun, Kim Jung Kwon, Ku Ja Hyeon, Kwak Cheol, Kim Hyeon Hoe, Jeong Chang Wook
Department of Urology, Korea University Ansan Hospital, Ansan, South Korea.
Department of Urology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University Hospital, Seoul, South Korea.
BMC Surg. 2018 Jul 6;18(1):45. doi: 10.1186/s12893-018-0377-4.
Coated polyglactin 910 suture with chlorhexidine (NEOSORB® Plus) has recently been developed to imbue the parent suture with antibacterial activity against organisms that commonly cause surgical site infections (SSI). This prospective, single-blinded, randomized trial, was performed to compare the intraoperative handling and wound healing characteristics of NEOSORB® Plus with those of the traditional polyglactin 910 suture (NEOSORB®) in urologic surgery patients.
Patients (aged 19 to 80 years, n = 100) were randomized in a 1:1 ratio for treatment with either NEOSORB® Plus or NEOSORB®, and stratified into an open surgery or a minimally invasive surgery group. The primary endpoint was the assessment of overall intraoperative handling of the sutures. Secondary endpoints included specific intraoperative handling measures and wound healing characteristics. Wound healing was assessed at one and 11 days after surgery. Cumulative skin infection, seroma, and suture sinus events within 30 days after surgery were also evaluated.
A total of 96 patients were included, with 47 patients in the NEOSORB® Plus group and 49 patients in the NEOSORB® group. Scores for intraoperative handling were favorable and were not significantly different between the two suture groups. Wound healing characteristics were also comparable. The incidence of adverse events was 13.6%, although none were deemed attributable to the suture, and no difference was observed between the two groups.
NEOSORB® Plus is not inferior to traditional sutures in terms of intraoperative handling and wound healing, potentially making NEOSORB® Plus a beneficial alternative for patients at increased risk of SSI.
ClinicalTrials.gov: NCT02431039 . Trial registration date 14 August 2015.
含氯己定的聚乙醇酸910涂层缝线（NEOSORB® Plus）最近被研发出来，以使母体缝线具备针对通常导致手术部位感染（SSI）的微生物的抗菌活性。本前瞻性、单盲、随机试验旨在比较NEOSORB® Plus与传统聚乙醇酸910缝线（NEOSORB®）在泌尿外科手术患者中的术中操作和伤口愈合特征。
患者（年龄19至80岁，n = 100）按1:1比例随机分为接受NEOSORB® Plus或NEOSORB®治疗，并分层为开放手术组或微创手术组。主要终点是评估缝线的总体术中操作。次要终点包括特定的术中操作措施和伤口愈合特征。在术后1天和11天评估伤口愈合情况。还评估了术后30天内的累积皮肤感染、血清肿和缝线窦事件。
共纳入96例患者，NEOSORB® Plus组47例，NEOSORB®组49例。术中操作评分良好，两组缝线之间无显著差异。伤口愈合特征也具有可比性。不良事件发生率为13.6%，尽管没有不良事件被认为归因于缝线，两组之间也未观察到差异。
NEOSORB® Plus在术中操作和伤口愈合方面不劣于传统缝线，这可能使NEOSORB® Plus成为SSI风险增加患者的有益替代选择。
ClinicalTrials.gov：NCT02431039。试验注册日期2015年8月14日。
