Community leg ulcer bandaging study: lessons learned in a pilot, randomized controlled trial 

Compression is the cornerstone of venous leg ulcer (VLU) care but comparative effectiveness evidence is limited, especially regarding home care. In preparation for a large, community-based randomized controlled clinical trial (RCT), the "Canadian Bandaging Trial" (CBT), a pilot study was conducted to assess the practicality of the CBT study protocol. Nurses who provided home care also performed the research intervention and outcome measurements. All trial procedures were implemented to examine the following aspects of the study protocol: 1) eligibility screening, recruitment, enrollment, and randomization procedures; 2) integration of intervention protocol with usual clinical routines; 3) data collection and management and outcome measures; and 4) database creation and testing. Guided by a Pilot Research Process Framework (PReP), this 6-month pilot RCT was conducted at two community-based sites in Ontario, Canada. Participants included 12 persons with VLUs, 40 nurses providing leg ulcer care, and two site investigators. Individuals with a VLU were randomized to a four-layer or short-stretch compression bandage. Eligibility screening and randomization procedures were found to be efficient but the ratio of screened (49) versus enrolled (12) patients was low and suggested the need for nine additional clinical sites, a change in ulcer size eligibility, and research to evaluate how to incorporate persons with diabetes in leg ulcer trials. Screening practices, data collection form concerns, and wound photo assessment outcomes issues were addressed. The results of this study improved and streamlined the large RCT quality and processes and confirm the value of pilot studies. Research to test the usefulness of the PReP framework for other pilot studies is needed.