Murphy Patrick, Lee Kevin, Dubois Luc, DeRose Guy, Forbes Thomas, Power Adam
Division of General Surgery, Department of Surgery, Western University, 1151 Richmond Street, London, ON, N6A 5A5, Canada.
Division of Vascular Surgery, Department of Surgery, Western University, 800 Commissioners Road East, London, ON, N6A 4G5, Canada.
Trials. 2015 Nov 4;16:504. doi: 10.1186/s13063-015-1026-1.
Rates of surgical site infections (SSIs) following groin incision for femoral artery exposure are much higher than expected of a clean operation. The morbidity and mortality is high, particularly with the use of prosthetic grafts. The vascular surgery population is at an increased risk of SSIs related to peripheral vascular disease (PVD), diabetes, obesity, previous surgery and presence of tissue loss. Negative pressure wound therapy (NPWT) dressings have been used on primarily closed incisions to reduce surgical site infections in other surgical disciplines. We have not come across any randomized controlled trials to support the prophylactic use of negative pressure wound therapy in high-risk vascular patients undergoing lower limb revascularization.
METHODS/DESIGN: In this single-center, prospective randomized controlled trial, patients scheduled for a lower limb revascularization requiring open femoral artery exposure who are at a high risk (BMI > 30 kg/m(2), previous femoral cutdown or Rutherford V or VI category for chronic limb ischemia) will be eligible for the study. A total of 108 groin incisions will be randomized to the use of a negative pressure wound device or standard adhesive gauze dressing. Patients will be followed in hospital and reassessed within the first 30 days postoperatively. The primary outcome is SSI within the first 30 days of surgery and will be determined using the intention-to-treat principle. Secondary outcomes include length of stay, emergency room visits, reoperation, amputation and mortality. A cost analysis will be performed.
The trial is expected to define the role of NPWT in SSI prophylaxis for lower limb revascularization in high-risk vascular patients. The results of the study will be used to inform current best practice for perioperative care and the minimization of SSIs.
NCT02084017 , March 2014.
为暴露股动脉而进行腹股沟切口后的手术部位感染（SSI）发生率远高于清洁手术的预期。其发病率和死亡率很高，尤其是在使用人工血管移植物时。血管外科患者发生与周围血管疾病（PVD）、糖尿病、肥胖、既往手术以及组织缺失相关的手术部位感染的风险增加。负压伤口治疗（NPWT）敷料已主要用于闭合切口，以减少其他外科领域的手术部位感染。我们尚未发现任何随机对照试验来支持在接受下肢血运重建的高危血管患者中预防性使用负压伤口治疗。
方法/设计：在这项单中心、前瞻性随机对照试验中，计划进行需要切开暴露股动脉的下肢血运重建且处于高风险（体重指数>30kg/m²、既往股动脉切开或慢性肢体缺血的卢瑟福V或VI级）的患者将符合研究条件。总共108个腹股沟切口将被随机分为使用负压伤口装置或标准粘性纱布敷料。患者将在医院接受随访，并在术后30天内进行重新评估。主要结局是术后30天内的手术部位感染，并将采用意向性分析原则进行判定。次要结局包括住院时间、急诊就诊、再次手术、截肢和死亡率。将进行成本分析。
该试验有望确定负压伤口治疗在高危血管患者下肢血运重建手术部位感染预防中的作用。研究结果将用于为围手术期护理的当前最佳实践以及手术部位感染的最小化提供依据。
NCT02084017，2014年3月。
