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

摘要 手术部位感染（SSI）现在是最常见的一组医疗保健相关感染（HAI）， 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费用每年高达100亿美元。由于这些原因，他们 预防是美国卫生与公众服务部和美国疾病控制与预防研究所的首要任务。 药尽管有几项举措针对HAI，但很少针对剖宫产后SSI，尽管事实上， 剖腹产是妇女最常见的主要外科手术。 预防性负压伤口治疗在肥胖妇女剖宫产试验是一个大的实用 一项多中心随机临床试验，旨在评价 预防性负压伤口治疗（NPWT）-一种封闭的密封系统， 通过一次性、电池供电的便携式器械对伤口表面施加压力-以减少手术部位 感染（SSI）的肥胖妇女进行剖腹产。实验证据表明，NPWT 通过清除渗出物、缝合伤口边缘和减少细菌来促进伤口愈合 污染.与非肥胖者相比，肥胖增加了剖宫产和SSI的风险 妇女增加的风险部分是由于皮下空间的厚度增加， 收集渗出物并增加伤口边缘的张力，促进细菌的生长， 伤口感染和破裂因此，预防性NPWT可能对该患者特别有效 人口在为期5年的项目期间，来自4个合作国家的多学科调查小组 围产期中心（两所大学和两个社区）代表美国两个地区， 肥胖母亲将随机选择2,850名接受剖腹产的肥胖妇女， 使用PICOTM器械或标准伤口敷料进行预防性NPWT。 该项目的具体目标是：1）确定预防性NPWT在降低发生率方面的有效性 肥胖女性剖宫产后SSI的发生率（主要目的），2）评估肥胖女性预防性NPWT的安全性 通过不良事件（包括皮肤水疱、红斑和伤口出血）的频率测量女性 （次要目标#1）和3）评价预防性NPWT与标准NPWT相比的成本效益 肥胖女性的伤口敷料，通过每例SSI预防的增量成本和每例 质量调整生命年（次要目标#2）。这项研究的预期结果是高质量的，容易 预防性NPWT在降低 肥胖妇女剖宫产后的SSI如果证明有效，使用这种简单的设备在肥胖妇女，谁是在 剖宫产和随后SSI的高风险，将对术后 剖宫产发病率和相关的医疗费用。

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.