Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Multicenter Randomized Trial

肥胖女性剖腹产多中心随机试验的预防性负压伤口治疗

• 批准号: 9443985
• 负责人: Methodius Gamuo Tuuli
• 金额: $ 11.44万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-16 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9443985
• 关键词: Adverse event; Bacteria; Biological; Body mass index; Bulla; Cesarean section; Collection; Communities; Data; Devices; Dose; Effectiveness; Erythema; Exudate; Frequencies; Growth; Health Care Costs; Healthcare; Hemorrhage; Infection; Infection prevention; Institute of Medicine (U.S.); Institutes; Intervention; Measures; Minority; Morbid Obesity; Morbidity - disease rate; Non obese; Obesity; Operative Surgical Procedures; Outcome Study; Patients; Perinatal; Pregnancy; Prevention; Public Health; Publishing; Quality-Adjusted Life Years; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Research; Research Personnel; Retrospective cohort; Risk; Safety; Site; Skin; Sterile coverings; Surface; Surgical Wound Dehiscence; Surgical incisions; System; Testing; Thick; Time; United States; United States Dept. of Health and Human Services; Universities; Woman; Wound Healing; Wound Infection; cost; cost effective; cost effectiveness; cost-effectiveness evaluation; design; high risk; maternal obesity; mortality; multidisciplinary; open wound; patient population; portability; pressure; prophylactic; randomized trial; response; seal; standard care; subcutaneous; trial design; wound; wound closure

ABSTRACT Surgical site infections (SSIs) are now the most common group of healthcare associated infections (HAIs) and are a significant cause of preventable morbidity and mortality in the United States. These infections result in significant patient suffering and excess health care costs up to $10 billion each year. For these reasons, their prevention is a top priority for the U.S. Department of Health and Human Services and the Institute of Medicine. Although several initiatives target HAIs, few are directed at SSIs after cesarean despite the fact that cesarean is the most common major surgical procedure performed in women. The Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Trial is a large pragmatic multicenter randomized clinical trial designed to evaluate the effectiveness, safety and cost-effectiveness of prophylactic negative pressure wound therapy (NPWT) – a closed, sealed system that applies negative pressure to the wound surface via a single-use, battery-powered, portable device – to decrease surgical site infections (SSIs) in obese women undergoing cesarean delivery. Experimental evidence suggests that NPWT promotes wound healing by removing exudate, approximating the wound edges, and reducing bacterial contamination. Obesity increases the risk for both cesarean delivery and SSIs compared to non-obese women. The increased risk is in part due to the increased thickness of the subcutaneous space, allowing collection of exudates and increasing tension on wound edges, promoting the growth of bacteria, and leading to wound infection and breakdown. Thus, prophylactic NPWT may be particularly effective in this patient population. During the 5-year project period, a multidisciplinary team of investigators from 4 collaborating perinatal centers (two university and two community) representing two regions of the U.S. with high rates of maternal obesity will randomize 2,850 obese women undergoing cesarean delivery to receive either prophylactic NPWT with the PICOTM device or standard wound dressing. The specific aims of the project are: 1) Determine the effectiveness of prophylactic NPWT in reducing the rate of SSIs after cesarean in obese women (Primary Aim), 2) Assess the safety of prophylactic NPWT in obese women as measured by frequency of adverse events including skin blisters, erythema, and wound bleeding (Secondary Aim#1), and 3) Evaluate the cost-effectiveness of prophylactic NPWT compared with standard wound dressing in obese women as measured by the incremental cost per case of SSI prevented and per Quality-adjusted Life-year (Secondary Aim#2). The expected outcome of this study is high-quality, readily applicable, evidence on the effectiveness, safety, and cost-effectiveness of prophylactic NPWT in reducing SSIs after cesarean in obese women. If proven effective, use of this simple device in obese women, who are at high risk for both cesarean delivery and subsequent SSIs, will have an important positive impact on post- cesarean morbidity and associated healthcare costs.

摘要 手术部位感染(SSI)是目前最常见的医疗保健相关感染(HAI)和 是美国可预防的发病率和死亡率的重要原因。这些感染导致 严重的病人痛苦和过度的医疗保健每年花费高达100亿美元。出于这些原因，他们的 预防是美国卫生与公众服务部和美国卫生与公众服务研究所的首要任务 医学。尽管有几项举措是针对HAI的，但很少有人针对剖宫产后的SSI，尽管事实是 剖腹产是女性最常见的主要外科手术。 剖宫产中肥胖妇女的预防性负压伤口治疗是一项大规模的实用试验 多中心随机临床试验，旨在评估阿司匹林的有效性、安全性和成本效益 预防性负压创伤治疗(NPWT)--一种应用负压的封闭、密封系统 通过一次性使用、电池供电的便携式设备对伤口表面施加压力，以减少手术部位 接受剖腹产的肥胖妇女的感染(SSI)。实验证据表明，NPWT 通过去除渗出物、接近伤口边缘和减少细菌来促进伤口愈合 污染。与非肥胖相比，肥胖会增加剖腹产和SSI的风险 女人。风险增加的部分原因是皮下间隙的厚度增加， 收集渗出物并增加伤口边缘的张力，促进细菌的生长，并导致 伤口感染和崩溃。因此，预防性NPWT可能对该患者特别有效。 人口。在5年的项目期内，来自4个国家的多学科调查团队合作 围产期中心(两所大学和两个社区)，代表美国两个发病率较高的地区 母亲肥胖将随机选择2850名接受剖腹产的肥胖女性 使用PICOTM装置或标准创面敷料进行预防性NPWT。 该项目的具体目标是：1)确定预防性NPWT在降低发病率方面的有效性 肥胖症妇女剖宫产后SSI的评估(主要目的)，2)评价肥胖症患者预防性NPWT的安全性 以皮肤水泡、红斑和伤口出血等不良事件的频率来衡量女性 (次要目标1)，以及3)与标准相比，评价预防性NPWT的成本-效果 肥胖妇女的创面敷料，以每例预防和每例SSI的增量成本衡量 经质量调整的生命年(次级目标2)。这项研究的预期结果是高质量的，容易的 预防性NPWT的有效性、安全性和成本效益的适用证据 肥胖妇女剖宫产后的SSI。如果被证明有效，在肥胖女性中使用这种简单的设备，她们在 剖宫产和随后的SSI的高风险将对后遗症产生重要的积极影响 剖腹产发病率和相关的医疗费用。