Prophylactic dressings for preventing sacral pressure injuries in adult intensive care unit patients: A randomised feasibility trial

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.