METHODS: We perform a single-center, randomized-controlled, superiority trial in favor of the preoperative decolonization using a commercial product (octenidine® set). We will randomize a total number of 1000 adult elective orthopedic patients with a high risk for SSI and/or wound complications (age ≥ 80 years, chronic immune-suppression, American Society of Anesthesiologists score 3-4 points) between a decolonization (octenisan® wash lotion 1 × per day and octenisan® md nasal gel 2-3 × per day; during 5 days) and no decolonization. Decolonized patients will additionally fill a questionnaire regarding the practical difficulties, the completeness, and the adverse events of decolonization. The primary outcomes are SSI and revision surgeries for postoperative wound problems until 6 weeks postoperatively (or 1 year for surgeries with implants or bone). Secondary outcomes are unplanned revision surgeries for non-infectious problems and all adverse events. With 95% event-free surgeries in the decolonization arm versus 90% in the control arm, we formally need 2 × 474 elective orthopedic surgeries included during 2 years.
CONCLUSIONS: In selected adult orthopedic patients with a high risk for SSI, the presurgical decolonization may reduce postoperative wound problems, including SSI.
BACKGROUND: ClinicalTrial.gov NCT05647252. Registered on 9 December 2022.
METHODS: 2 (5 December 2022).
方法:我们执行单中心,随机对照,有利于使用商业产品(奥替尼定®组)进行术前脱色的优势试验。我们将随机分配1000名成人择期骨科患者,这些患者具有SSI和/或伤口并发症的高风险(年龄≥80岁,慢性免疫抑制,美国麻醉医师协会评分3-4分)在脱色(octenisan®洗液每天1次和octenisan®md鼻凝胶每天2-3次之间;在5天内)和无脱色。去殖民地的患者将额外填写一份关于实际困难的问卷,的完整性,以及非殖民化的不良事件。主要结果是术后伤口问题的SSI和翻修手术,直到术后6周(或植入物或骨手术1年)。次要结局是非感染性问题和所有不良事件的计划外修正手术。去定植组95%的无事件手术与对照组90%的无事件手术,我们正式需要在2年内纳入2×474例择期骨科手术。
结论:在选定的SSI高风险成人骨科患者中,术前脱色可以减少术后伤口问题,包括SSI。
背景:ClinicalTrial.govNCT05647252。2022年12月9日注册
方法:2(2022年12月5日)。