López-Parra Maria, Gil-Rey Dolors, López-González Esmeralda, González-Rodríguez Eva-Maria, Simó-Sánchez Isabel, Zamora-Carmona Francisco, Roqueta-Andreu Lidia, Arizu-Puigvert Marta, Abril-Sabater Dolors, Moreno-Álvarez Àngels, López-Bonet Àngels, López-Hidalgo Gisela, Costa-Ventura Helena, García-Pardo Laura, Rico-Liberato Mireia, García-Borràs Miriam, Arnal-Leris Maria Teresa, Sianes-Gallén Mònica, Vives Roser
Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc Taulí 1, 08208 Sabadell, Barcelona, Spain.
Capresa, prevención de riesgos laborales, C/ Badajoz, 145, 08018, Barcelona, Spain.
Trials. 2018 Jul 5;19(1):357. doi: 10.1186/s13063-018-2755-8.
Surgical wounds are covered to prevent bleeding, absorb the exudates, and provide a barrier against external contamination. Currently, in our hospital, after orthopedic surgery, traditional occlusive dressing of sterile gauze and non-woven hypoallergenic adhesive tape is placed. Some of the newest dressings have been shown to reduce the incidence of blisters compared with traditional dressing or colloid adhesive dressings. However, there are no comparative evaluations between the different types of dressings and their contribution to the overall results of the healing process.
METHODS/DESIGN: This is a randomized, controlled, open-label trial to compare five types of dressings used in total knee and hip arthroplasty surgical wounds. A total of 550 patients will be randomly allocated to one of the following dressings: (1) traditional occlusive dressing, (2) Aquacel Surgical, (3) Mepilex Border Post-Op, (4) OpSite Post-Op Visible, or (5) UrgoTul Absorb Border. The dressing assigned is placed right after surgery. Patients will be followed up to 14 days after surgery when the dressing is definitively removed and will be tracked up to 3 months to record any late complications. During the immediate postoperative period and patient hospitalization and at the ambulatory visits after discharge, every time that the dressing is changed, nurses perform the study assessments. The main study outcome will be the percentage of patients with skin integrity at all times when the dressing has been changed. Skin integrity is a composite of the absence of blisters, erosion, erythema, maceration, swelling, wound dehiscence, and purulent exudates. Secondary outcomes include time to first change of dressing; percentage of patients with presence/absence of blisters, erosion, erythema, maceration, swelling, wound dehiscence, and purulent exudates; number of dressing changes needed; days of hospital stay; and nurse and patient satisfaction. Differences in the main variable between each treatment group and group 1 will be tested by means of a chi-squared test or Fisher's exact test. Subgroup analyses of diabetic and non-diabetic patients, patients with a body mass index of more than 30 or not more than 30, and type of surgery (hip or knee) are planned.
The results of this study will be useful for clinical decision making by giving information on the contribution of the dressings studied to the outcome of the wound and may also show which dressing offers better results depending on the characteristics of patients.
This trial has been registered at ClinicalTrials.gov ( NCT03190447 ). Retrospectively registered on 16 June 2017.
手术伤口需进行覆盖，以防止出血、吸收渗出液，并提供抵御外部污染的屏障。目前，在我们医院，骨科手术后会使用无菌纱布和低敏无纺布胶带进行传统的封闭敷料包扎。与传统敷料或胶体粘性敷料相比，一些最新的敷料已被证明可降低水泡的发生率。然而，不同类型的敷料之间及其对愈合过程整体结果的贡献尚无比较评估。
方法/设计：这是一项随机、对照、开放标签试验，旨在比较全膝关节和髋关节置换手术伤口使用的五种类型的敷料。总共550名患者将被随机分配至以下一种敷料组：（1）传统封闭敷料；（2）爱康肤银离子藻酸盐敷料；（3）美皮康术后加强型敷料；（4）优拓SSD术后可视敷料；或（5）优格透吸收性边框敷料。分配的敷料在手术后立即放置。患者将在手术后随访14天，届时敷料将被最终拆除，并将跟踪3个月以记录任何晚期并发症。在术后即刻、患者住院期间以及出院后的门诊就诊时，每次更换敷料时，护士进行研究评估。主要研究结果将是每次更换敷料时始终保持皮肤完整性的患者百分比。皮肤完整性是水泡、糜烂、红斑、浸渍、肿胀、伤口裂开和脓性渗出物均不存在的综合表现。次要结果包括首次更换敷料的时间；出现/未出现水泡、糜烂、红斑、浸渍、肿胀、伤口裂开和脓性渗出物的患者百分比；所需更换敷料的次数；住院天数；以及护士和患者的满意度。每个治疗组与第1组之间主要变量的差异将通过卡方检验或费舍尔精确检验进行测试。计划对糖尿病和非糖尿病患者、体重指数大于或不大于30的患者以及手术类型（髋关节或膝关节）进行亚组分析。
本研究结果将有助于临床决策，提供有关所研究敷料对伤口愈合结果贡献的信息，还可能表明根据患者特征哪种敷料效果更佳。
本试验已在ClinicalTrials.gov注册（NCT03190447）。于2017年6月16日进行回顾性注册。
