Department of Vascular Surgery, Maastricht University Medical Centre, the Netherlands.
Department of Surgery, Zuyderland Medical Centre, Heerlen, the Netherlands.
Eur J Vasc Endovasc Surg. 2020 Apr;59(4):635-641. doi: 10.1016/j.ejvs.2020.01.010. Epub 2020 Feb 21.
The aim of this study was to assess the effectiveness of gentamicin containing collagen implants in the reduction of surgical site infections (SSIs) in patients undergoing an inguinal incision for vascular surgery.
Prospective blinded randomised controlled multicentre trial (RCT), performed in four hospitals in The Netherlands and Belgium. This study included 288 patients who underwent an inguinal incision for primary arterial repair (femoral endarterectomy, femorofemoral or femoropopliteal bypass, aortobifemoral bypass, thrombectomy, embolectomy, endovascular aneurysm repair) between October 2012 and December 2015. Patients were randomised to receive a gentamicin implant (study group) or no implant (control group). The calculated sample sizes of 304 patients per group were not reached. Primary outcome was SSI incidence after six weeks. Secondary outcomes were time to onset of infection, length of hospital stay, allergic reactions, treatment with antibiotics, need for re-admission, re-operation and mortality.
One hundred fifty-one patients were allocated to the study group (mean age 69 ± 9.2 years) and 137 patients were allocated to the control group (mean age 70 ± 10.4 years). Both groups were homogeneous regarding baseline and intra-operative characteristics. Gentamicin implants did not result in a significant overall reduction of SSIs in the study group (7% vs. 12%, p = .17). In a post hoc analysis comparing two study sites with low (<10%) and two study sites with high (>10%) infection rates in the control group, gentamicin implants significantly reduced SSIs in high risk centres (22% vs. 1%, p < .001), whereas there was no significant effect in low risk centres (13% vs. 7%, p = .30). There were no allergic reactions and all secondary outcomes were comparable between groups.
Gentamicin implants did not result in a significant overall reduction of SSIs in this RCT. Gentamicin implants did reduce the incidence of SSIs in high risk centres and may be a valuable adjunct to improve outcomes in such vascular centres with a high incidence of wound infections. However, the limitation of not reaching the calculated sample sizes should be considered.
本研究旨在评估含庆大霉素胶原植入物在减少血管外科腹股沟切口手术部位感染（SSI）方面的有效性。
这是一项在荷兰和比利时的四家医院进行的前瞻性、盲法、随机对照多中心试验（RCT）。本研究纳入了 2012 年 10 月至 2015 年 12 月期间因原发性动脉修复（股动脉内膜切除术、股股或股腘旁路、主动脉-双股旁路、血栓切除术、取栓术、血管内动脉瘤修复）而行腹股沟切口的 288 例患者。将患者随机分为接受庆大霉素植入物（研究组）或不植入（对照组）。每组计算的 304 例样本量未达到。主要结局为 6 周后的 SSI 发生率。次要结局包括感染发病时间、住院时间、过敏反应、抗生素治疗、再入院、再次手术和死亡率。
151 例患者被分配至研究组（平均年龄 69±9.2 岁），137 例患者被分配至对照组（平均年龄 70±10.4 岁）。两组患者的基线和术中特征均具有同质性。研究组庆大霉素植入物并未显著降低 SSI 的总体发生率（7%比 12%，p=0.17）。在一项比较两组感染率较低（<10%）和两组感染率较高（>10%）的研究中心的事后分析中，庆大霉素植入物显著降低了高风险中心的 SSI 发生率（22%比 1%，p<0.001），而在低风险中心则无显著影响（13%比 7%，p=0.30）。两组均未发生过敏反应，次要结局也相似。
在这项 RCT 中，庆大霉素植入物并未显著降低 SSI 的总体发生率。庆大霉素植入物可降低高风险中心的 SSI 发生率，可能是改善高感染发生率的血管中心治疗结果的有效辅助手段。然而，应考虑未达到计算样本量的局限性。
