Prophylactic dressing to minimize sacral pressure injuries in high risk hospitalised patients: A pilot study

Abstract

AIM: 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. BACKGROUND: 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. DESIGN: Randomized controlled trial. METHODS: 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. DISCUSSION: 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.