Study protocol for the groin wound infection after vascular exposure (GIVE) audit and multicentre cohort study
Study protocol for the groin wound infection after vascular exposure (GIVE) audit and multicentre cohort study
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DOI：
10.1016/j.isjp.2019.06.001
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发表时间：
2019-01-01
影响因子：
0.9
通讯作者：
Bosanquet, David Charles
中科院分区：
文献类型：
--
作者：
Gwilym, Brenig Llwyd;Saratzis, Athanasios;Bosanquet, David Charles
简介：腹股沟切口动脉暴露后的手术部位感染（SSI）是常见的，也是大动脉手术后发病率和死亡率的重要原因。公布的发病率差异很大。GIVE的主要目的是将个别单位的做法与国家健康和护理卓越研究所（NICE）的既定指导方针进行比较。次要目的是描述接受腹股沟切口动脉暴露的患者的SSI当代发生率，确定腹股沟伤口感染的风险因素，检查已发表的工具在SSI预测中的价值，确定可在未来疗效/有效性试验中检查的平衡区域，并将英国SSI发生率与国际中心进行比较。方法和分析：这项国际、多中心、前瞻性观察性研究将通过血管和血管内研究网络（VERN）进行。参与中心将确定连续3个月内接受清洁急诊或择期腹股沟切口动脉介入治疗的所有患者。将在术后90天采集随访数据。SSI将根据疾病控制和预防中心（CDC）的标准定义。将使用匿名电子数据收集工具或安全电子邮件传输集中收集数据。伦理和传播：本研究将在所有参与的英国中心注册为临床稽查;不需要研究伦理批准。国家领导人将根据需要监督英国以外国家的适当注册和批准。将向各参与中心提供研究中心特定SSI发生率报告。研究结果将在每个研究中心在当地传播，在社交媒体上公布，并提交同行评审出版物。(C)2019作者由Elsevier Ltd代表Surgical Associates Ltd发布。
Introduction: Surgical site infections (SSIs) following groin incision for arterial exposure are commonplace and a significant cause of morbidity and mortality following major arterial surgery. Published incidence varies considerably. The primary aim of GIVE will be to compare individual units' practice with established guidelines from The National Institute for Health and Care Excellence (NICE). Secondary aims will be to describe the contemporary rate of SSI in patients undergoing groin incision for arterial exposure, to identify risk factors for groin wound infection, to examine the value of published tools in the prediction of SSI, to identify areas of equipoise which could be examined in future efficacy/effectiveness trials and to compare UK SSI rates with international centres.Methods and analysis: This international, multicentre, prospective observational study will be delivered via the Vascular and Endovascular Research Network (VERN). Participating centres will identify all patients undergoing clean emergency or elective groin incision(s) for arterial intervention during a consecutive 3-month period. Follow up data will be captured at 90 days after surgery. SSIs will be defined according to the Centres for Disease Control and Prevention (CDC) criteria. Data will be gathered centrally using an anonymised electronic data collection tool or secure email transfer.Ethics and dissemination: This study will be registered as a clinical audit at all participating UK centres; research ethics approval is not required. National leads will oversee the appropriate registration and approvals in countries outside the UK as required. Site specific reports of SSI rates will be provided to each participating centre. Study results will be disseminated locally at each site, publicised on social media and submitted for peer-reviewed publication. (C) 2019 The Authors. Published by Elsevier Ltd on behalf of Surgical Associates Ltd.