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含银水凝胶敷料与聚维酮碘纱布用于开放性手术伤口和创伤伤口处理的随机临床试验

Randomised clinical trial of Hydrofiber dressing with silver versus povidone-iodine gauze in the management of open surgical and traumatic wounds.

作者信息

Jurczak Florent, Dugré Thierry, Johnstone Alison, Offori Theodor, Vujovic Zorica, Hollander Dirk

机构信息

Polyclinique de l'Océan, Saint Nazaire, France.

出版信息

Int Wound J. 2007 Mar;4(1):66-76. doi: 10.1111/j.1742-481X.2006.00276.x.

Abstract

This prospective, randomised clinical trial compared pain, comfort, exudate management, wound healing and safety with Hydrofiber dressing with ionic silver (Hydrofiber Ag dressing) and with povidone-iodine gauze for the treatment of open surgical and traumatic wounds. Patients were treated with Hydrofiber Ag dressing or povidone-iodine gauze for up to 2 weeks. Pain severity was measured with a 10-cm visual analogue scale (VAS). Other parameters were assessed clinically with various scales. Pain VAS scores decreased during dressing removal in both groups, and decreased while the dressing was in place in the Hydrofiber Ag dressing group (n = 35) but not in the povidone-iodine gauze group (n = 32). Pain VAS scores were similar between treatment groups. At final evaluation, Hydrofiber Ag dressing was significantly better than povidone-iodine gauze for overall ability to manage pain (P < 0.001), overall comfort (P < or = 0.001), wound trauma on dressing removal (P = 0.001), exudate handling (P < 0.001) and ease of use (P < or = 0.001). Rates of complete healing at study completion were 23% for Hydrofiber Ag dressing and 9% for povidone-iodine gauze (P = ns). No adverse events were reported with Hydrofiber Ag dressing; one subject discontinued povidone-iodine gauze due to adverse skin reaction. Hydrofiber Ag dressing supported wound healing and reduced overall pain compared with povidone-iodine gauze in the treatment of open surgical wounds requiring an antimicrobial dressing.

摘要

这项前瞻性随机临床试验比较了含离子银的水凝胶敷料(水凝胶银敷料)和聚维酮碘纱布在治疗开放性手术伤口和创伤伤口时的疼痛、舒适度、渗出液管理、伤口愈合及安全性。患者接受水凝胶银敷料或聚维酮碘纱布治疗长达2周。疼痛严重程度采用10厘米视觉模拟量表(VAS)进行测量。其他参数通过各种量表进行临床评估。两组在去除敷料时疼痛VAS评分均下降,在水凝胶银敷料组(n = 35)中,敷料在位时评分也下降,但聚维酮碘纱布组(n = 32)则不然。治疗组之间的疼痛VAS评分相似。在最终评估中,在整体疼痛管理能力(P < 0.001)、整体舒适度(P ≤ 0.001)、去除敷料时的伤口创伤(P = 0.001)、渗出液处理(P < 0.001)和易用性(P ≤ 0.001)方面,水凝胶银敷料显著优于聚维酮碘纱布。研究结束时,水凝胶银敷料的完全愈合率为23%,聚维酮碘纱布为9%(P = 无显著性差异)。水凝胶银敷料未报告不良事件;一名受试者因皮肤不良反应停用了聚维酮碘纱布。在治疗需要抗菌敷料的开放性手术伤口时,与聚维酮碘纱布相比,水凝胶银敷料有助于伤口愈合并减轻整体疼痛。

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