Walker Rachel, Aitken Leanne M, Huxley Leisa, Juttner Melanie
NHMRC Centre of Research Excellence in Nursing (NCREN), Griffith University & Princess Alexandra Hospital, Centre for Health Practice Innovation, Griffith Health Institute, Griffith University, Brisbane, Queensland, Australia.
J Adv Nurs. 2015 Mar;71(3):688-96. doi: 10.1111/jan.12543. Epub 2014 Oct 9.
In this paper, we describe a trial protocol used to assess feasibility related to: study administration (recruitment, randomization, retention, compliance, eligibility criteria, suitability of protocol instructions and data collection questionnaires); resource and data management (suitability of site, time and budget allocation, management of personnel and data); intervention fidelity (treatment dose, violations); and effect size.
Pressure injury can lead to increases in hospital length of stay and cost. The sacrum is identified as one of the most common anatomical pressure injury sites for hospitalized patients. Silicone foam border dressings have been proposed as one strategy to reduce pressure injury incidence; however, rigorous testing of benefit in a general medical-surgical population is required.
Randomized controlled trial.
Eighty patients will be recruited after assessment of high risk of pressure injury in a large tertiary hospital in south-east Queensland, Australia. Eligible, consenting participants will be randomly allocated to either a control group (routine care) or an intervention group (routine care and a sacral prophylactic dressing). The primary outcomes comprise feasibility criteria as identified above. The secondary measure is the presence and severity of sacral pressure injury via blind assessment of digital photographs. Research ethics approval was received in October 2013.
Prophylactic dressings applied to the sacrum may be an effective method for reducing pressure injury in high-risk general medical-surgical patients. However, more rigorous studies to confirm benefit are required. This pilot study will determine the feasibility and effect size to inform a larger randomized controlled trial.
在本文中，我们描述了一个试验方案，用于评估与以下方面相关的可行性：研究管理（招募、随机分组、保留率、依从性、纳入标准、方案说明和数据收集问卷的适用性）；资源和数据管理（研究地点的适用性、时间和预算分配、人员和数据管理）；干预保真度（治疗剂量、违规情况）；以及效应量。
压力性损伤会导致住院时间延长和费用增加。骶骨被确定为住院患者中最常见的解剖学压力性损伤部位之一。硅酮泡沫边缘敷料已被提议作为降低压力性损伤发生率的一种策略；然而，需要在普通内科-外科人群中对其益处进行严格测试。
随机对照试验。
在澳大利亚昆士兰州东南部的一家大型三级医院，对80名被评估为有高压力性损伤风险的患者进行招募。符合条件且同意参与的参与者将被随机分配到对照组（常规护理）或干预组（常规护理加骶骨预防性敷料）。主要结局包括上述确定的可行性标准。次要指标是通过对数码照片进行盲法评估来确定骶骨压力性损伤的存在情况和严重程度。2013年10月获得了研究伦理批准。
应用于骶骨的预防性敷料可能是降低高危普通内科-外科患者压力性损伤的有效方法。然而，需要更严格的研究来证实其益处。这项试点研究将确定可行性和效应量，为更大规模的随机对照试验提供依据。
