Latimer Sharon, Chaboyer Wendy, Walker Rachel M, Thalib Lukman, Deakin Jodie L, Gillespie Brigid M
NHMRC Centre of Research Excellence in Wiser Wound Care, School of Nursing and Midwifery, Griffith University, Gold Coast, QLD, Australia.
Division of Surgery, Metro South Health, Princess Alexandra Hospital, Brisbane, QLD, Australia; School of Nursing and Midwifery, Griffith University, Meadowbrook, QLD, Australia.
Aust Crit Care. 2025 Mar;38(2):101133. doi: 10.1016/j.aucc.2024.101133. Epub 2024 Nov 15.
Prophylactic dressings are used to prevent sacral pressure injuries (PIs) in intensive care unit (ICU) patients. Bedside clinicians are responsible for selecting these dressings despite the lack of comparative evidence.
The objective of this study was to assess the feasibility of undertaking a larger multisite comparative effectiveness trial of two prophylactic sacral dressings in adult ICU patients.
Using a two-arm pilot randomised feasibility trial design, we randomly allocated adult ICU patients to the Mepilex® Border Sacrum dressing or Allevyn™ Life Sacrum dressing plus usual PI prevention care. Our primary study outcomes were study eligibility, recruitment, retention, intervention fidelity, and missing data criteria. Participants were followed up for up to 14 days or a study endpoint: new sacral PI, ICU discharge, death, prone positioning, urine/faecal incontinence, or withdrawal. Daily clinical data were collected including a deidentified sacral photograph, sacral visual skin assessment, dressing failure rates (rolled edges, adhesion loss), and dressing-related harm (e.g., blisters). The blinded outcome assessor used these data to determine the presence of a new sacral PI.
From January to September 2023, 1069 ICU patients were screened; 77 (7.2%) were eligible, and 68 (88.3%) were recruited. Half of our feasibility criteria were met. One participant (1.5%) developed a sacral PI. Throughout the study, half (n = 54; 49.5%) of the dressing changes were due to dressing failure (rolled edges: n = 43; 79.5%, adhesion failure: n = 11; 20.5%).
Several prophylactic sacral dressings are available; however, comparative effective evidence between brands relative to performance, benefits, and harms is lacking. Following minor study criteria modifications, we found that a larger multisite comparative trial is feasible. Sacral prophylactic dressing failure and dressing-related harms are care quality and patient safety issues requiring further investigation regarding performance, harm, and costs.
Australian and New Zealand Clinical Trial Registration number: ACTRN12622000793718 and World Health Organization Universal Trial number: U1111-1278-6055.
预防性敷料用于预防重症监护病房（ICU）患者的骶骨压力性损伤（PI）。尽管缺乏比较证据，但床边临床医生负责选择这些敷料。
本研究的目的是评估在成年ICU患者中对两种预防性骶骨敷料进行更大规模的多中心比较有效性试验的可行性。
采用双臂试点随机可行性试验设计，我们将成年ICU患者随机分配至美皮康®骶骨边缘敷料或爱立肤™骶骨敷料加常规PI预防护理。我们的主要研究结局为研究合格性、招募、保留、干预保真度和缺失数据标准。对参与者进行长达14天的随访或直至研究终点：新发骶骨PI、ICU出院、死亡、俯卧位、尿/粪失禁或退出研究。收集每日临床数据，包括匿名的骶骨照片、骶骨皮肤视觉评估、敷料失败率（卷边、粘连丧失）和与敷料相关的伤害（如水泡）。盲法结局评估者使用这些数据确定是否存在新发骶骨PI。
2023年1月至9月，筛查了1069例ICU患者；77例（7.2%）符合条件，68例（88.3%）被招募。我们的可行性标准有一半得到满足。1例参与者（1.5%）发生骶骨PI。在整个研究过程中，一半（n = 54；49.5%）的敷料更换是由于敷料失败（卷边：n = 43；79.5%；粘连失败：n = 11；20.5%）。
有几种预防性骶骨敷料可供使用；然而，缺乏不同品牌之间关于性能效益和危害的比较有效证据。在对研究标准进行 minor 修改后，我们发现更大规模的多中心比较试验是可行的。骶骨预防性敷料失败和与敷料相关的伤害是护理质量和患者安全问题，需要对性能、伤害和成本进行进一步调查。
澳大利亚和新西兰临床试验注册号：ACTRN12622000793718，世界卫生组织通用试验号：U1111 - 1278 - 6055。
