Abstract:
Wound Rep Reg (2012) DOI:10.1111/j.1524-475X.2012.00799.x Reprint requests:
Dr. D. T. Ubbink, Department of Quality
Assurance and Process Innovation,
A3-503, Academic Medical Center,
Meibergdreef 9, PO Box 22700, 1100 DE
Amsterdam, the Netherlands.
Tel: +31 20 566 6892;
Fax: +31 20 566 4440
Email: d.ubbink@amc.nl
Manuscript received: May 5, 2011
Accepted in final form: February 27, 2012The care for chronic and acute wounds is a substantial problem around the world. This has led to a plethora of products to accelerate healing. Unfortunately, the quality of studies evaluating the efficacy of such wound care products is frequently low.
Randomized clinical trials are universally acknowledged as the study design of
choice for comparing treatment effects, as they eliminate several sources of bias.We
propose a framework for the design and conduct of future randomized clinical trials
that will offer strong scientific evidence for the effectiveness of wound care interventions.
While randomization is a necessary feature of a robust comparative study,
it is not sufficient to ensure a study at low risk of bias. Randomized clinical trials
should also ensure adequate allocation concealment and blinding of outcome assessors, apply intention-to-treat analysis, and use patient-oriented outcomes. This article proposes strategies for improving the evidence base for wound care decision making.
