School of Healthcare, University of Leeds, Leeds, UK.
BMJ Open. 2013 Jan 4;3(1):e002370. doi: 10.1136/bmjopen-2012-002370.
Accurate identification of pathogens, rather than colonising bacteria, is a prerequisite for targeted antibiotic therapy to ensure optimal patient outcome in wounds, such as diabetic foot ulcers. Wound swabs are the easiest and most commonly used sampling technique but most published guidelines recommend instead removal of a tissue sample from the wound bed, which is a more complex process. The aim of this study was to assess the concordance between culture results from wound swabs and tissue samples in patients with suspected diabetic foot infection.
Patients with a diabetic foot ulcer that is thought to be infected are being recruited from 25 sites across England in a cross-sectional study. The coprimary endpoints for the study are agreement between the two sampling techniques for three microbiological parameters: reported presence of likely isolates identified by the UK Health Protection Agency; resistance of isolates to usual antibiotic agents; and, the number of isolates reported per specimen. Secondary endpoints include appropriateness of the empiric antibiotic therapy prescribed and adverse events. Enrolling 400 patients will provide 80% power to detect a difference of 3% in the reported presence of an organism, assuming organism prevalence of 10%, discordance of 5% and a two-sided test at the 5% level of significance. Assumed overall prevalence is based on relatively uncommon organisms such as Pseudomonas. We will define acceptable agreement as κ>0.6.
Concordance in diabetic foot ulcer infection (CODIFI) will produce robust data to evaluate the two most commonly used sampling techniques employed for patients with a diabetic foot infection. This will help determine whether or not it is important that clinicians take tissue samples rather than swabs in infected ulcers. This study has been approved by the Sheffield NRES Committee (Ref: 11/YH/0078) and all sites have obtained local approvals prior starting recruitment.
NRES Ref: 11/YH/0078, UKCRN ID: 10440, ISRCTN: 52608451.
准确识别病原体，而不是定植细菌，是进行靶向抗生素治疗的前提，以确保糖尿病足溃疡等伤口患者获得最佳疗效。伤口拭子是最简便、最常用的采样技术，但大多数已发表的指南建议，取而代之的是从伤口床中取出组织样本，这是一个更为复杂的过程。本研究旨在评估疑似糖尿病足感染患者的伤口拭子和组织样本培养结果之间的一致性。
本横断面研究在英格兰 25 个地点招募疑似糖尿病足溃疡感染的患者。该研究的主要终点是两种采样技术在三个微生物学参数上的一致性：英国健康保护署（UK Health Protection Agency）报告的可能分离株的存在情况；分离株对常用抗生素药物的耐药性；以及每份标本报告的分离株数量。次要终点包括经验性抗生素治疗的适宜性和不良事件。招募 400 名患者将提供 80%的效能，以检测到报告存在的一种生物体的差异为 3%，假设生物体流行率为 10%，不匹配率为 5%，双侧检验的显著性水平为 5%。假设的总体流行率基于相对罕见的生物体，如假单胞菌。我们将可接受的一致性定义为 κ>0.6。
糖尿病足溃疡感染的一致性（CODIFI）将产生稳健的数据，以评估用于糖尿病足感染患者的两种最常用的采样技术。这将有助于确定临床医生在感染性溃疡中是否重要，是否需要采集组织样本而不是拭子。本研究已获得谢菲尔德 NRES 委员会（Ref：11/YH/0078）的批准，所有参与单位在开始招募前均已获得当地的批准。
NRES 注册号：11/YH/0078，UKCRN 注册号：10440，ISRCTN：52608451。
