E. Andrea Nelson, Sarah T. Brown, Colin C. Everett, Angela Oates, Michael Backhouse, Howard Collier, Joanna Dennett, Rachael Gilberts, Ben Lipsky, Michelle M. Lister, Jane E. Nixon, David Russell, Tim Sloan, Fran Game
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Allocation was via a central and independent randomisation system, with minimisation by DFU site, number, type, size, location, and duration.</p>\n \n <p>Follow-up was 52–104 weeks, with healing confirmed by a blinded assessor. Samplesize target was 730 participants for 90% power to detect a 12.5% difference in healing at 52 weeks.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Between May 2019 and May 2022, 149 participants were recruited (75 Swab, 74 Tissue) from 21 UK sites. The 52-week cumulative incidence of confirmed healing as the first event was 45.3% (33.5%–56.4%) and 44.6% (33.0–55.6%) for swab vs. tissue. The hazard ratio (HR) for healing for tissue vs. swab was 1.01 (95% CI 0.65–1.55). The median (IQR) days in hospital was 17 (12–39) for swab and 16 (10–32) for tissue. Seventeen swab and 7 tissue participants died during follow-up, and 18.7% and 24.3% of participants in the swab and tissue groups, respectively, had an amputation.</p>\n </section>\n \n <section>\n \n <h3> Conclusions/Interpretation</h3>\n \n <p>This trial was underpowered to determine whether swab or tissue sampling impacted the rate of healing or time to healing. 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引用次数: 0
摘要
目的/假设：CODIFI2比较了感染糖尿病足溃疡（DFU）患者的伤口擦拭和组织取样，以确定对临床结果的影响。方法：多中心，III期，前瞻性，非盲，双臂平行组，随机对照试验，比较溃疡愈合时间（主要结局），愈合比例，抗菌方案，溃疡面积减少，住院时间和拭子与组织取样的死亡时间。通过中央和独立的随机系统进行分配，根据DFU的地点、数量、类型、大小、位置和持续时间进行最小化。随访52-104周，经盲法评估证实愈合。样本量目标为730名参与者，在52周内检测到12.5%的愈合差异。结果：2019年5月至2022年5月期间，从英国21个地点招募了149名参与者（75名拭子，74名组织）。第一次确诊愈合的52周累积发生率分别为45.3%（33.5%-56.4%）和44.6%（33.0-55.6%）。组织与拭子愈合的风险比（HR）为1.01 （95% CI 0.65-1.55）。拭子住院的中位（IQR）天数为17（12-39）天，组织住院的中位（IQR）天数为16（10-32）天。17例拭子组和7例组织组在随访期间死亡，分别有18.7%和24.3%的拭子组和组织组的参与者截肢。结论/解释：该试验不足以确定拭子或组织取样是否影响愈合率或愈合时间。两组间临床处方和患者预后略有差异；因此，组织取样的临床效益尚未确定。
CODIFI2: Randomised controlled trial to compare clinical and cost-effectiveness of swabs versus tissue sampling to inform management of infected diabetic foot ulcers
BAims/Hypothesis
CODIFI2 compared wound swabbing and tissue sampling in people with infected diabetic foot ulcers (DFU) to determine the effects on clinical outcomes.
Methods
Multicentre, Phase III, prospective, non-blind, 2-arm parallel group, randomised controlled trial comparing time to ulcer healing (primary outcome), proportions healed, antimicrobial regimen, ulcer area reduction, hospitalisation duration, and time to death for swab compared to tissue sampling. Allocation was via a central and independent randomisation system, with minimisation by DFU site, number, type, size, location, and duration.
Follow-up was 52–104 weeks, with healing confirmed by a blinded assessor. Samplesize target was 730 participants for 90% power to detect a 12.5% difference in healing at 52 weeks.
Results
Between May 2019 and May 2022, 149 participants were recruited (75 Swab, 74 Tissue) from 21 UK sites. The 52-week cumulative incidence of confirmed healing as the first event was 45.3% (33.5%–56.4%) and 44.6% (33.0–55.6%) for swab vs. tissue. The hazard ratio (HR) for healing for tissue vs. swab was 1.01 (95% CI 0.65–1.55). The median (IQR) days in hospital was 17 (12–39) for swab and 16 (10–32) for tissue. Seventeen swab and 7 tissue participants died during follow-up, and 18.7% and 24.3% of participants in the swab and tissue groups, respectively, had an amputation.
Conclusions/Interpretation
This trial was underpowered to determine whether swab or tissue sampling impacted the rate of healing or time to healing. Clinical prescribing and patient outcomes differed slightly between groups; hence, the clinical benefit of tissue sampling is not established.
期刊介绍：
Diabetic Medicine, the official journal of Diabetes UK, is published monthly simultaneously, in print and online editions.
The journal publishes a range of key information on all clinical aspects of diabetes mellitus, ranging from human genetic studies through clinical physiology and trials to diabetes epidemiology. We do not publish original animal or cell culture studies unless they are part of a study of clinical diabetes involving humans. Categories of publication include research articles, reviews, editorials, commentaries, and correspondence. All material is peer-reviewed.
We aim to disseminate knowledge about diabetes research with the goal of improving the management of people with diabetes. The journal therefore seeks to provide a forum for the exchange of ideas between clinicians and researchers worldwide. Topics covered are of importance to all healthcare professionals working with people with diabetes, whether in primary care or specialist services.
Surplus generated from the sale of Diabetic Medicine is used by Diabetes UK to know diabetes better and fight diabetes more effectively on behalf of all people affected by and at risk of diabetes as well as their families and carers.”
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