Fundamentals of randomized clinical trials in wound care: design and conduct.
The 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.
Department of Quality Assurance and Process Innovation, University of Amsterdam, Amsterdam, the Netherlands.
Anne M
AM
Eskes
Fleur E
FE
Brölmann
Bauer E
BE
Sumpio
Dieter
D
Mayer
Zena
Z
Moore
Magnus S
MS
Agren
Michel
M
Hermans
Keith
K
Cutting
Dink A
DA
Legemate
Dirk T
DT
Ubbink
Hester
H
Vermeulen
D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use; D057189:Checklist; D003646:Debridement / Q000379:methods; D003695:Delivery of Health Care / Q000592:standards*; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D014945:Wound Healing; D014947:Wounds and Injuries / Q000628:therapy*
D000900:Anti-Bacterial Agents; D000891:Anti-Infective Agents, Local