A Randomized Trial of Ionic Silver Dressing to Reduce Surgical Site Infection After Gastrointestinal Surgery

C. Kosugi, Keiji Koda, Hiroaki Shimizu, M. Yamazaki, K. Shuto, M. Mori, Akihiro Usui, Hiroyuki Nojima, Satoshi Endo, H. Yanagibashi, H. Arimitsu, Toru Tochigi, T. Sazuka, Mihono Hirota, Hideyuki Kuboki
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Abstract

To determine whether Aquacel Ag Hydrofiber dressings containing ionic silver are superior to film dressings for preventing superficial surgical site infections (SSI) in patients undergoing elective gastrointestinal surgery. Multiple clinical trials have assessed the effectiveness of silver-containing wound dressings; however, systematic reviews failed to find any advantages of these dressings and concluded that there was insufficient evidence to indicate that they prevented wound infections. This study aimed to evaluate the efficacy of Aquacel Ag Hydrofiber dressings for preventing superficial SSIs in patients undergoing gastrointestinal surgery. Patients undergoing elective gastrointestinal surgery were randomly assigned to receive either Aquacel Ag Hydrofiber (study group) or film dressings (control group). The primary end point was superficial SSI within 30 days after surgery (UMIN Clinical Trials Registry ID: 000043081). A total of 865 patients (427 study group, 438 control group) were qualified for primary end-point analysis. The overall rate of superficial SSIs was significantly lower in the study group than in the control group (6.8% vs 11.4%, P = 0.019). There was no significant difference in superficial SSI rates between the groups in patients undergoing upper gastrointestinal surgery; however, the rate was significantly lower in the study group in patients undergoing lower gastrointestinal surgery (P = 0.042). Multivariate analysis identified Aquacel Ag Hydrofiber dressings as an independent factor for reducing superficial SSIs (odds ratio, 0.602; 95% confidence interval, 0.367–0.986; P = 0.044). Aquacel Ag Hydrofiber dressings can reduce superficial SSIs compared to film dressings in patients undergoing elective gastrointestinal surgery, especially lower gastrointestinal surgery.
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离子银敷料减少胃肠道手术后手术部位感染的随机试验
目的:确定 Aquacel Ag Hydrofiber 含离子银敷料在预防接受择期胃肠道手术的患者浅表手术部位感染 (SSI) 方面是否优于薄膜敷料。 多项临床试验对含银伤口敷料的有效性进行了评估;然而,系统性综述未能发现这些敷料的任何优点,并得出结论认为没有足够的证据表明它们能预防伤口感染。本研究旨在评估 Aquacel Ag Hydrofiber 敷料对胃肠道手术患者预防浅表 SSI 的疗效。 接受择期胃肠道手术的患者被随机分配到 Aquacel Ag Hydrofiber(研究组)或薄膜敷料(对照组)。主要终点是术后 30 天内的表皮 SSI(UMIN 临床试验注册编号:000043081)。 共有 865 名患者(研究组 427 人,对照组 438 人)符合主要终点分析条件。研究组的浅表 SSI 总发生率明显低于对照组(6.8% vs 11.4%,P = 0.019)。在接受上消化道手术的患者中,研究组与对照组的浅表 SSI 感染率无明显差异;但在接受下消化道手术的患者中,研究组的感染率明显较低(P = 0.042)。多变量分析发现,Aquacel Ag 水纤维敷料是减少浅表 SSI 的一个独立因素(几率比 0.602;95% 置信区间 0.367-0.986;P = 0.044)。 与薄膜敷料相比,Aquacel Ag 水纤维敷料可减少接受择期胃肠道手术(尤其是下胃肠道手术)患者的浅表 SSI。
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