Abstract
PURPOSE: The purpose of this pilot study was to inform a future trial aimed at comparing the effectiveness of a prophylactic sacral dressing plus standard care to standard care only to reduce sacral pressure injuries (PIs) in at-risk older adults admitted to a subacute hospital setting.
DESIGN: A pilot study with a pragmatic, open-label, randomized controlled trial design.
SAMPLE AND SETTING: One hundred thirty participants were randomized (intervention n = 66, 50.8%; control n = 64, 49.2%). Protocol violations occurred in 48 participants (intervention n = 33, 68.8%; control n = 15, 31.3%). The study setting was a subacute hospital inpatient care unit located in Queensland, Australia.
METHODS: Participants were randomly allocated 1:1 to the intervention (prophylactic dressing plus standard care) or control group (standard care). Standard care included regular PI risk and skin assessments, and selection and implementation of preventive interventions (eg, support surfaces and increased repositioning) from a PI prevention care plan. The sacral dressing was applied for intervention participants immediately following recruitment. Ward and research staff collected data and assessed skin integrity daily; participants were followed up until onset of a PI or up to 28 days without PI occurrence. In addition, retrospective chart reviews were undertaken to verify PI occurrences. Patient comfort and dressing utility were also evaluated.
RESULTS: Two (3.0%) participants in the intervention group and 1 (1.6%) in the control group developed a sacral PI. The difference was not statistically significant. Only 1 PI was recorded prospectively, while 2 PIs were identified via retrospective chart review. Participants rated dressing comfort highly, particularly during the first 2 weeks, and nurses rated utility highly. Based on the intention-to-treat results, a sample size of 1799 per arm would be required in a definitive trial.
CONCLUSIONS: A definitive trial is feasible and warranted. However, the large sample size required in a definitive trial indicates the need for multiple sites.