PDF(Pubmed)
Abstract：
BACKGROUND: The preoperative body surface and nasal decolonization may reduce the risk of surgical site infections (SSI) but yields conflicting results in the current orthopedic literature.
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).
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).
摘要：
背景：术前体表和鼻腔脱色可能会降低手术部位感染（SSI）的风险，但在目前的骨科文献中产生矛盾的结果。
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）。
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）。
