A methodology for evaluating wound care products in complex chronic wounds

Background: The question of whether particular methodologies can generate knowledge of a sufficiently rigorous and relevant standard to guide patients’ interventions is regularly debated. This debate tends to be polarised between those who advocate the randomised controlled trial (RCT) as the ultimate scientific methodology and those who find RCTs wanting in terms of the information derived and their limited generalisability beyond the immediate trial population. This paper argues for a suite of methodologies that can evaluate wound care interventions; it also details a novel methodology for use in complex chronic and palliative wound care. Aim: To outline a methodology that can evaluate the clinical performance of wound care products in the context of complex treatment and care. Methods: The methodology is informed by the UK Medical Research Council framework for the design of complex evaluations, and is an N-of-1 design. Results: A novel methodology for evaluating the effectiveness of wound care technologies in complex chronic wound care and palliative wound care has been proposed. Conclusion: The methodology requires validation in prospective studies. The purpose of this paper is to open a constructive debate. Conflict of interest: None. Abstract