In 2014 NICE published MTG20 guidance on Parafricta® bootees and undergarments, designed to reduce friction and associated shear which can result in pressure ulcers. The guidance recommended that further research should take place to inform a decision on whether routine adoption of the products in the NHS should be supported. NICE commissioned Cedar to undertake a research study. In collaboration with the Welsh Wound Innovation Centre, Cedar designed a randomised controlled trial to compare, in hospitalised patients, whether Parafricta® bootees, added to standard care (SC), prevent heel pressure ulcers compared to standard alone. Cedar secured a research grant from the Health and Care research Wales ‘Research for Patient and Public Benefit’ programme of value £216,463 and an agreement from APA Parafricta Ltd to supply Parafricta® bootees at no cost to the study. Cedar gained all research governance and ethical approvals to initiate the study. Immobile hospital patients at high risk of tissue damage (defined as Waterlow score ≥ 20) and no heel pressure ulcers at baseline were randomly allocated to either Parafricta® bootees plus standard care, or standard care alone. The target sample size was 450 patients. Patients’ heels were clinically assessed for incident heel pressure ulcers at Day 3 and Day 14. Slow recruitment stopped the study early. The investigators reported sustained difficulty in recruiting eligible hospital patients. The study was terminated early.
In 31 recruited patients there were zero incident heel pressure ulcers (intervention group, 0%) versus 1 (standard care group, 6%) at Day 3 and no new heel pressure ulcers at Day 14. The study failed to reach sufficient statistical power to assess the efficacy of Parafricta® bootees in preventing heel pressure ulcers. No adverse events were related to the bootees. Only 1 patient in the standard care group developed a heel pressure ulcer.
Cedar carried out the following trial management roles: