静脉注射与口服及静脉联合抗菌药物预防（COMBINE）在择期结直肠手术中预防手术部位感染的比较：一项多中心、双盲、随机对照临床试验的研究方案
Comparison of intravenous versus combined oral and intravenous antimicrobial prophylaxis (COMBINE) for the prevention of surgical site infection in elective colorectal surgery: study protocol for a multicentre, double-blind, randomised controlled clinical trial.
作者信息
Vignaud Marie, Paugam-Burtz Catherine, Garot Matthias, Jaber Samir, Slim Karem, Panis Yves, Lucet Jean-Christophe, Bourdier Justine, Morand Dominique, Pereira Bruno, Futier Emmanuel
机构信息
Département Anesthésie et Réanimation, Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Estaing, Clermont-Ferrand, France.
Assistance publique-Hôpitaux de Paris (AP-HP), Département Anesthésie Réanimation, Hôpital Beaujon, Hôpitaux Universitaires Paris Nord Val de Seine, Paris, France.
出版信息
BMJ Open. 2018 Apr 12;8(4):e020254. doi: 10.1136/bmjopen-2017-020254.
INTRODUCTION
Surgical site infections (SSIs) account for 30% of all healthcare-associated infections, with reported rates ranging from 8% and 30% after colorectal surgery and are associated with increased morbidity and mortality rates, length of hospital stay and costs in healthcare. Administration of systemic antimicrobial prophylaxis before surgery is recommended to reduce the risk of SSI, but the optimal regimen remains unclear. We aim to evaluate whether a combined oral and intravenous antimicrobial prophylaxis could be more effective to reduce the incidence of SSI after colorectal surgery, as compared with the standard practice of intravenous antimicrobial prophylaxis alone.
METHODS AND ANALYSIS
Comparison of intravenous versus combined oral and intravenous antimicrobial prophylaxis (COMBINE) trial is a randomised, placebo-controlled, parallel, double-blind, multicentre study of 960 patients undergoing elective colorectal surgery. Patients will be randomly allocated in a 1:1 ratio to receive either combined oral and intravenous antimicrobial prophylaxis or intravenous antibiotic prophylaxis alone, stratified by centre, the surgical procedure (laparoscopic or open surgery) and according to the surgical skin antisepsis (chlorexidine-alcohol or povidione-iodine alcoholic solution). The primary endpoint is the rate of SSI by day 30 following surgery, with SSI defined by the criteria developed by the Centers for Disease Control and Prevention. Data will be analysed on the intention-to-treat principle and a per-protocol basis.
ETHICS AND DISSEMINATION
COMBINE trial has been approved by an independent ethics committee for all study centres. Participant recruitment began in May 2016. Results will be published in international peer-reviewed medical journals.
TRIAL REGISTRATION NUMBER
EudraCT 2015-002559-84; NCT02618720.
引言
手术部位感染（SSIs）占所有医疗相关感染的30%，据报道，结直肠手术后的感染率在8%至30%之间，并且与发病率和死亡率增加、住院时间延长以及医疗费用增加相关。建议在手术前给予全身性抗菌预防以降低手术部位感染的风险，但最佳方案仍不明确。我们旨在评估与单独静脉注射抗菌预防的标准做法相比，口服和静脉联合抗菌预防是否能更有效地降低结直肠手术后手术部位感染的发生率。
方法与分析
静脉注射与口服和静脉联合抗菌预防（COMBINE）试验是一项随机、安慰剂对照、平行、双盲、多中心研究，涉及960例接受择期结直肠手术的患者。患者将按1:1的比例随机分配，接受口服和静脉联合抗菌预防或单独静脉注射抗生素预防，按中心、手术方式（腹腔镜或开放手术）以及手术皮肤消毒方式（洗必泰酒精或聚维酮碘酒精溶液）进行分层。主要终点是术后30天的手术部位感染率，手术部位感染根据美国疾病控制与预防中心制定的标准定义。数据将按照意向性分析原则和符合方案集进行分析。
伦理与传播
COMBINE试验已获得所有研究中心独立伦理委员会的批准。参与者招募于2016年5月开始。结果将发表在国际同行评审的医学期刊上。
试验注册号
EudraCT 2015 - 002559 - 84；NCT02618720。
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