Wound management products--the evidence we need and the difficulties in obtaining it

The management of complex wounds requires the expertise and co-ordinated effort of multiple disciplines in a variety of healthcare settings. Providers of wound care will be held increasingly responsible for the impact of clinical and economic outcomes for the patient, healthcare system and, ultimately, society as a whole. Collecting and analysing outcome data and comparing it to regional and national standards, will be the method which demonstrates the quality of service provided. This paper will review the design implications for conducting comparisons of therapies used in the management of wounds. Consideration will be given to overall design, sample size calculations, clinical setting, choice of comparator and mechanisms for exploring how efficacy and cost data can be linked. Evidence obtained from several prospective randomised clinical trials will be used as examples to support the theoretical considerations.