评估二烷基氨基甲酰氯（DACC）涂层术后敷料与标准护理在清洁或清洁-污染性血管手术中预防手术部位感染的效果（DRESSINg试验）：一项初步可行性随机对照试验的研究方案
Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial.
作者信息
Totty Joshua P, Harwood Amy E, Cai Paris L, Hitchman Louise H, Smith George E, Chetter Ian C
机构信息
Academic Vascular Surgical Unit, Hull Royal Infirmary, Anlaby Road, Hull, HU3 2JZ UK.
出版信息
Pilot Feasibility Stud. 2019 Jan 18;5:11. doi: 10.1186/s40814-019-0400-2. eCollection 2019.
BACKGROUND
Surgical site infection in vascular surgery has a reported incidence of up to 19%. A novel method of reducing this rate of infection is dressings coated with dialkylcarbamoylchloride (DACC), a hydrophobic wound contact layer that binds bacteria and removes them from the wound bed. Early research has suggested that DACC-coated wound dressings are effective in reducing surgical site infection when applied to wounds healing by primary intention post-operatively, therefore this trial aims to assess the feasibility of producing high-quality evidence assessing this theory.
METHODS
Patients undergoing clean or clean-contaminated vascular surgery will be randomised to have their surgical wounds dressed with a DACC-coated dressing or a non-coated occlusive absorbent post-operative dressing. All other aspects of their peri-operative care will be standardised or carried out in line with hospital policy. Wound assessments will be carried out between day 5-7, day 30 (± 3 days) and 6 months post-operatively (± 7 days) by a blinded assessor using the ASEPSIS scoring tool. Quality of life data using EQ-5D and SF-36, resource use and mortality data will also be collected. This feasibility trial will dictate the conduct of a full-scale trial through the collection of data on recruitment and retention rates, and fitness-for-purpose of the follow-up arrangements.
DISCUSSION
Surgical site infections are now the second most common hospital acquired infections with a significant cost implication. The aim of the DRESSINg trial is to investigate the effectiveness of a novel preventative measure at reducing wound infections post-surgery and will provide robust evidence to support or deny its use.
TRIAL REGISTRATION
Clinicaltrials.gov identifier: NCT02992951, Registered 12/12/16. REC Reference: 16/LO/2135.
背景
血管外科手术部位感染的报告发生率高达19%。一种降低感染率的新方法是使用涂有二烷基氨基甲酰氯（DACC）的敷料，这是一种疏水性伤口接触层，可结合细菌并将其从伤口床清除。早期研究表明，术后一期愈合的伤口使用涂有DACC的伤口敷料可有效减少手术部位感染，因此本试验旨在评估产生高质量证据以评估该理论的可行性。
方法
接受清洁或清洁-污染性血管手术的患者将被随机分配，其手术伤口分别使用涂有DACC的敷料或未涂覆的术后闭塞性吸收性敷料。围手术期护理的所有其他方面将标准化或按照医院政策进行。在术后第5至7天、第30天（±3天）和6个月（±7天），由一名盲法评估者使用ASEPSIS评分工具进行伤口评估。还将收集使用EQ-5D和SF-36的生活质量数据、资源使用情况和死亡率数据。这项可行性试验将通过收集关于招募和保留率以及随访安排是否适用的数据，来决定是否进行全面试验。
讨论
手术部位感染现在是第二常见的医院获得性感染，具有重大的成本影响。DRESSINg试验的目的是研究一种新型预防措施在减少术后伤口感染方面的有效性，并将提供有力证据支持或否定其使用。
试验注册
Clinicaltrials.gov标识符：NCT02992951，于2016年12月12日注册。REC参考号：16/LO/2135。
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