多中心、双盲、随机对照临床试验：比较间歇性头孢西丁给药与负荷剂量推注后持续输注用于预防结直肠手术手术部位感染的效果——PROPHYLOXITIN研究方案
Multicentre, double-blind, randomised controlled clinical trial comparing intermittent cefoxitin administration versus loading bolus followed by continuous infusion for the prevention of surgical site infection in colorectal surgery: the PROPHYLOXITIN study protocol.
作者信息
Saint-Genis Quentin, Birckener Julien, Gourdou Vincent, Nicolle Claire, Garnier Marc, Schwindenhammer Victor, Hannezo Cécile, Aveline Christophe, Cinotti Raphaël, Puisney Benjamin, Garot Matthias, Chevalier Stéphanie, Aubert Jean-Sébastien, Wodey Maxime, Lasocki Sigismond, Lecoeur Sylvain, Lagarrigue Charles Jean, Li Anne, Faucher Marion, Foucher Yohann, Frasca Denis, Boisson Matthieu
机构信息
Université de Poitiers, INSERM U1070 PHAR2, CHU de Poitiers, Service d'Anesthésie-Réanimation et Médecine Péri-Opératoire, Poitiers, France.
CHRU de Nancy, Nancy, France.
出版信息
BMJ Open. 2025 Jan 28;15(1):e088306. doi: 10.1136/bmjopen-2024-088306.
INTRODUCTION
Surgical site infections (SSIs) are the second leading cause of healthcare-associated infections in Europe with the highest rates being reported in colorectal surgery (ranging from 9% to 30%). Surgical antibiotic prophylaxis (SAP) is one of the most efficient measures for SSI prevention and should be started before surgical incision. Cefoxitin is an antibiotic widely used as SAP for colorectal surgery, but its continuous administration is currently the subject of debate due to its potential pharmacokinetic advantages. Therefore, the aim of the PROPHYLOXITIN study is to demonstrate that a loading dose followed by continuous infusion of cefoxitin during colorectal surgery (intervention group) decreases the rate of SSI compared to an intermittent bolus administration (control group).
METHODS AND ANALYSIS
The PROPHYLOXITIN study is a superiority, prospective, double-blind, randomised and multicentre study of 2000 patients undergoing colorectal surgery. The primary objective is to demonstrate the superiority of a loading dose of cefoxitin followed by continuous infusion over intermittent bolus administration in reducing the proportion of SSIs within 30 days after colorectal surgery. Subjects will be randomised 1:1 using a secure web-based random-number generator to one of two study groups. Randomised allocation of treatment will be done by minimisation and stratified according to the centre, the localisation of surgery (colon or rectum) and the type of surgical procedure (laparoscopy or laparotomy).
ETHICS AND DISSEMINATION
This research has been approved by an independent ethics committee and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
EudraCT 2022-003262-20 and Clinical trial NCT05755789.
引言
手术部位感染（SSIs）是欧洲医疗保健相关感染的第二大主要原因，结直肠手术的感染率最高（9%至30%）。手术抗生素预防（SAP）是预防SSIs最有效的措施之一，应在手术切口前开始使用。头孢西丁是一种广泛用作结直肠手术SAP的抗生素，但由于其潜在的药代动力学优势，其持续给药目前存在争议。因此，PROPHYLOXITIN研究的目的是证明在结直肠手术期间，先给予负荷剂量然后持续输注头孢西丁（干预组）与间歇性推注给药（对照组）相比，可降低SSIs的发生率。
方法与分析
PROPHYLOXITIN研究是一项针对2000例接受结直肠手术患者的优效性、前瞻性、双盲、随机和多中心研究。主要目的是证明在结直肠手术后30天内，先给予负荷剂量头孢西丁然后持续输注优于间歇性推注给药，以降低SSIs的比例。将使用基于网络的安全随机数生成器按1:1的比例将受试者随机分配到两个研究组之一。治疗的随机分配将通过最小化方法进行，并根据中心、手术部位（结肠或直肠）和手术类型（腹腔镜手术或开腹手术）进行分层。
伦理与传播
本研究已获得独立伦理委员会的批准，并将按照《赫尔辛基宣言》和《良好临床实践指南》的原则进行。本研究的结果将通过在科学会议上发表和在同行评审期刊上发表来传播。
试验注册号
EudraCT 2022-003262-20和临床试验NCT05755789。
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