Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27710, USA.
N Engl J Med. 2010 Sep 9;363(11):1038-49. doi: 10.1056/NEJMoa1000837. Epub 2010 Aug 4.
Despite the routine use of prophylactic systemic antibiotics, surgical-site infection continues to be associated with significant morbidity and cost after colorectal surgery. The gentamicin-collagen sponge, an implantable topical antibiotic agent, is approved for surgical implantation in 54 countries. Since 1985, more than 1 million patients have been treated with the sponges.
In a phase 3 trial, we randomly assigned 602 patients undergoing open or laparoscopically assisted colorectal surgery at 39 U.S. sites to undergo either the insertion of two gentamicin-collagen sponges above the fascia at the time of surgical closure (the sponge group) or no intervention (the control group). All patients received standard care, including prophylactic systemic antibiotics. The primary end point was surgical-site infection occurring within 60 days after surgery, as adjudicated by a clinical-events classification committee that was unaware of the study-group assignments.
The incidence of surgical-site infection was higher in the sponge group (90 of 300 patients [30.0%]) than in the control group (63 of 302 patients [20.9%], P=0.01). Superficial surgical-site infection occurred in 20.3% of patients in the sponge group and 13.6% of patients in the control group (P=0.03), and deep surgical-site infection in 8.3% and 6.0% (P=0.26), respectively. Patients in the sponge group were more likely to visit an emergency room or surgeon's office owing to a wound-related sign or symptom (19.7%, vs. 11.0% in the control group; P=0.004) and to be rehospitalized for surgical-site infection (7.0% vs. 4.3%, P=0.15). The frequency of adverse events did not differ significantly between the two groups.
Our large, multicenter trial shows that the gentamicin-collagen sponge is not effective at preventing surgical-site infection in patients who undergo colorectal surgery; paradoxically, it appears to result in significantly more surgical-site infections. (Funded by Innocoll Technologies; ClinicalTrials.gov number, NCT00600925.)
尽管预防性全身使用抗生素已成为常规，但结直肠手术后手术部位感染仍会导致显著的发病率和费用增加。氨基糖苷类抗生素-胶原海绵是一种可植入的局部抗生素，已在 54 个国家获得用于手术植入的批准。自 1985 年以来，已有超过 100 万名患者接受了该海绵的治疗。
在一项 3 期临床试验中，我们将 39 个美国地点的 602 名接受开放式或腹腔镜辅助结直肠手术的患者随机分为两组，一组在筋膜闭合时插入两块氨基糖苷类抗生素-胶原海绵（海绵组），另一组不干预（对照组）。所有患者均接受标准护理，包括预防性全身抗生素。主要终点是手术后 60 天内发生的手术部位感染，由一个对研究分组不知情的临床事件分类委员会裁定。
海绵组（300 例患者中有 90 例[30.0%]）的手术部位感染发生率高于对照组（302 例患者中有 63 例[20.9%]，P=0.01）。海绵组有 20.3%的患者发生浅表手术部位感染，对照组为 13.6%（P=0.03）；深部手术部位感染分别为 8.3%和 6.0%（P=0.26）。海绵组的患者因伤口相关症状或体征（19.7%，vs. 对照组 11.0%；P=0.004）而更有可能去急诊室或看医生，并且因手术部位感染而再次住院的（7.0%，vs. 对照组 4.3%；P=0.15）的患者更多。两组的不良事件发生率无显著差异。
我们的大型多中心试验表明，氨基糖苷类抗生素-胶原海绵不能有效预防结直肠手术患者的手术部位感染；矛盾的是，它似乎导致了更多的手术部位感染。（由 Innocoll 技术公司资助；ClinicalTrials.gov 编号，NCT00600925）。
