Broach Robyn B, Paulson Emily C, Scott Charles, Mahmoud Najjia N
*Department of Surgery, Hospital of the University of Pennsylvania, 3400 Spruce Street, 4 Silverstein, Philadelphia, PA †Department of General Surgery, VA Medical Center, Philadelphia, PA ‡CBS Squared, Inc., CBS Squared, Inc., Flourtown, PA.
Ann Surg. 2017 Dec;266(6):946-951. doi: 10.1097/SLA.0000000000002189.
To compare 2 alcohol-based, dual-action skin preparations for surgical site infection (SSI) prevention in elective colorectal surgery.
Colorectal surgery is associated with the highest SSI rate among elective surgical procedures. Although evidence indicates that alcohol-based skin preparations are superior in SSI prevention, it is not clear if different alcohol-based preparations are equivalent in clean-contaminated colorectal procedures.
We performed a blinded, randomized, noninferiority trial comparing iodine povacrylex-alcohol (IPA) and chlorhexidine-alcohol for elective, clean-contaminated colorectal surgery. The primary outcome was the presence or absence of SSI, defined as superficial or deep SSI, within 30 days postdischarge. A 6.6% noninferiority margin was chosen.
Between January 2011 and January 2015, 802 patients were randomized with 788 patients included in the intent to treat analysis (396 IPA and 392 chlorhexidine-alcohol). The difference in overall SSI rate between IPA (18.7%) and chlorhexidine-alcohol (15.9%) was 2.8% (P = 0.30). The upper bound of the 2.5% confidence interval of this difference was 8.9%, which is greater than the prespecified noninferiority margin of 6.6%. Other endpoints, including individual SSI types, time to SSI diagnosis, and length of stay were not different between the 2 arms.
In patients undergoing elective, clean contaminated colorectal surgery, the use of IPA failed to meet criterion for noninferiority for overall SSI prevention compared with chlorhexidine-alcohol. Photodocumentation of wounds and rigorous tracking of outcomes up to 30 days postdischarge contributed to high fidelity to current standard SSI descriptions and wound classifications.
比较两种用于择期结直肠手术预防手术部位感染（SSI）的含酒精双效皮肤制剂。
在择期外科手术中，结直肠手术的SSI发生率最高。尽管有证据表明含酒精皮肤制剂在预防SSI方面更具优势，但在清洁-污染的结直肠手术中，不同的含酒精制剂是否等效尚不清楚。
我们进行了一项双盲、随机、非劣效性试验，比较聚维酮碘酒精（IPA）和氯己定酒精用于择期、清洁-污染结直肠手术的效果。主要结局是出院后30天内是否存在SSI，定义为浅表或深部SSI。选择了6.6%的非劣效性界值。
2011年1月至2015年1月期间，802例患者被随机分组，788例患者纳入意向性分析（396例使用IPA，392例使用氯己定酒精）。IPA组（18.7%）和氯己定酒精组（15.9%）的总体SSI发生率差异为2.8%（P = 0.30）。该差异的2.5%置信区间上限为8.9%，大于预先设定的6.6%非劣效性界值。其他终点，包括个体SSI类型、SSI诊断时间和住院时间，两组之间没有差异。
在接受择期、清洁-污染结直肠手术的患者中，与氯己定酒精相比，使用IPA未能达到总体预防SSI的非劣效性标准。伤口的照片记录以及出院后长达30天的严格结局追踪有助于高度符合当前SSI的标准描述和伤口分类。
