一项混合方法的可行性和外部预试验研究，为一项关于手术伤口敷料策略对手术部位感染影响的大型实用性随机对照试验提供信息（蓝铃花B期）：一项随机对照试验的研究方案
A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial.
作者信息
Reeves Barnaby C, Andronis Lazaros, Blazeby Jane M, Blencowe Natalie S, Calvert Melanie, Coast Joanna, Draycott Tim, Donovan Jenny L, Gooberman-Hill Rachael, Longman Robert J, Magill Laura, Mathers Jonathan M, Pinkney Thomas D, Rogers Chris A, Rooshenas Leila, Torrance Andrew, Welton Nicky J, Woodward Mark, Ashton Kate, Bera Katarzyna D, Clayton Gemma L, Culliford Lucy A, Dumville Jo C, Elliott Daisy, Ellis Lucy, Gould-Brown Hannah, Macefield Rhiannon C, McMullan Christel, Pope Caroline, Siassakos Dimitrios, Strong Sean, Talbot Helen
机构信息
School of Clinical Sciences, University of Bristol, Bristol, UK.
Health Economics Unit, School of Health and Population Sciences, University of Birmingham, Birmingham, UK.
出版信息
Trials. 2017 Aug 29;18(1):401. doi: 10.1186/s13063-017-2102-5.
BACKGROUND
Surgical site infections (SSIs) are common, occurring in up to 25% of > 4 million operations performed in England each year. Previous trials of the effect of wound dressings on the risk of developing a SSI are of poor quality and underpowered.
METHODS/DESIGN: This study is a feasibility and pilot trial to examine the feasibility of a full trial that will compare simple dressings, no dressing and tissue-glue as a dressing. It is examining the overall acceptability of trial participation, identifying opportunities for refinement, testing the feasibility of and validating new outcome tools to assess SSI, wound management issues and patients' wound symptom experiences. It is also exploring methods for avoiding performance bias and blinding outcome assessors by testing the feasibility of collecting wound photographs taken in theatre immediately after wound closure and, at 4-8 weeks after surgery, taken by participants themselves or their carers. Finally, it is identifying the main cost drivers for an economic evaluation of dressing types. Integrated qualitative research is exploring acceptability and reasons for non-adherence to allocation. Adults undergoing primary elective or unplanned abdominal general surgery or Caesarean section are eligible. The main exclusion criteria are abdominal or other major surgery less than three months before the index operation or contraindication to dressing allocation. The trial is scheduled to recruit for nine months. The findings will be used to inform the design of a main trial.
DISCUSSION
This pilot trial is the first pragmatic study to randomise participants to no dressing or tissue-glue as a dressing versus a simple dressing. Early evidence from the ongoing pilot shows that recruitment is proceeding well and that the interventions are acceptable to participants. Combined with the qualitative findings, the findings will inform whether a main, large trial is feasible and, if so, how it should be designed.
TRIAL REGISTRATION
ISRCTN49328913 . Registered on 20 October 2015.
背景
手术部位感染（SSIs）很常见，在英国每年超过400万例手术中，发生率高达25%。以往关于伤口敷料对发生手术部位感染风险影响的试验质量较差且效能不足。
方法/设计：本研究是一项可行性和预试验，旨在检验一项全面试验的可行性，该全面试验将比较简单敷料、不使用敷料以及使用组织胶水作为敷料的情况。它正在研究试验参与的总体可接受性，确定改进的机会，测试评估手术部位感染、伤口管理问题和患者伤口症状体验的新结局工具的可行性并进行验证。它还在探索避免执行偏倚和使结局评估者盲法的方法，即测试在伤口闭合后立即在手术室拍摄伤口照片以及在术后4 - 8周由参与者本人或其护理人员拍摄伤口照片的可行性。最后，它正在确定敷料类型经济评估的主要成本驱动因素。综合定性研究正在探索可接受性以及不遵守分配的原因。接受初次择期或非计划腹部普通外科手术或剖宫产的成年人符合条件。主要排除标准是在索引手术前不到三个月进行过腹部或其他大手术或存在敷料分配的禁忌证。该试验计划招募九个月。研究结果将用于为主要试验的设计提供信息。
讨论
这项预试验是第一项将参与者随机分为不使用敷料或使用组织胶水作为敷料与简单敷料进行比较的实用性研究。正在进行的预试验的早期证据表明招募进展顺利，并且干预措施为参与者所接受。结合定性研究结果，这些结果将为一项主要的大型试验是否可行以及如果可行应如何设计提供信息。
试验注册
ISRCTN49328913。于2015年10月20日注册。
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