The DECREASE SSI Trial (Decolonization to Reduce After-Surgery Events of Surgical Site Infection)

DECREASE SSI 试验（去殖民化以减少手术部位感染的术后事件）

• 批准号: 10501944
• 负责人: Susan S. Huang
• 金额: $ 49.48万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10501944
• 关键词: DECREASE; SSI; Trial; Decolonization; Reduce

Abstract The DECREASE SSI Trial (Decolonization to Reduce After-Surgery Events of Surgical Site Infection) Colon and small bowel surgery are high-volume, high-cost surgeries performed in over 675,000 patients in the United States each year. These surgeries carry one of the highest surgical site infection (SSI) rates, with estimates of 11-45%, or 2- to 3-fold higher than nationally reported rates, when comprehensive surveillance efforts are used, such as in clinical trials. Comprehensive tracking also uncovers a disproportionate amount of post-discharge incisional SSIs. These incisional SSIs are strongly tied to patient anxiety, stress, embarrassment, dissatisfaction, and lower quality of life scores. Mounting evidence shows that social and economic disadvantage can adversely affect the risk of SSI, likely due to the differential ability to protect a fresh incision from infection after hospital discharge. The Decolonization to Reduce After-Surgery Events of Surgical Site Infection (DECREASE SSI) Trial will test the value of adding a post-operative intervention to current pre-operative and intra-operative prevention practices. The DECREASE SSI Trial is a multi-site pragmatic randomized controlled clinical trial comparing routine post- discharge wound care to a post-discharge decolonization regimen of chlorhexidine bathing and nasal iodophor to prevent SSI events in the 30 days following discharge for open colon and small bowel surgery. If successful, this trial will provide a simple prevention measure for the 675,000 persons who undergo non-laparoscopic surgery involving the small and large intestines each year.

摘要 DECREASE SSI试验（减少术后手术部位感染事件的去殖民化） 结肠和小肠手术是高容量，高成本的手术，在超过675，000 美国每年的患者。这些手术是最高的手术部位感染（SSI）之一 综合而言，估计为11- 45%，比国家报告的比率高2- 3倍 在临床试验等方面进行监测。全面跟踪还揭示了一个 出院后切口SSI的数量不成比例。这些切口SSI与患者 焦虑、压力、尴尬、不满和较低的生活质量评分。 越来越多的证据表明，社会和经济劣势可能对SSI的风险产生不利影响， 这可能是由于出院后保护新切口免受感染的能力不同。的 去殖民化以减少术后手术部位感染事件（DECREASE SSI）试验将测试 在目前的术前和术中预防做法中增加术后干预的价值。 DECREASE SSI试验是一项多中心实用随机对照临床试验，比较常规术后 出院后洗必泰沐浴和鼻用碘伏的去殖民化方案 以防止开放性结肠和小肠手术出院后30天内发生SSI事件。如果成功， 该试验将为675，000名接受非腹腔镜手术的患者提供简单的预防措施 每年都有涉及小肠和大肠的手术。