Fundamentals of randomized clinical trials in wound care: Design and conduct

Abstract

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.

Human Wound-Healing Research: Issues and Perspectives for Studies Using Wide-Scale Analytic Platforms

“…Genome-wide techniques produce enormous amounts of data, and for proper analysis a bona fide professional is needed. 14,15 There is no standard clinical model available for chronic, nonhealing wounds, but the problem may be approached, to some extent, by studying normal wound healing. Split-thickness skin grafting is a standard procedure in many defects demanding skin cover; 0.01-inch-or 0.25-mm-thick grafts can be harvested in a very standardized way with a mechanical air-driven device (dermatome).…”

Fundamentals of randomized clinical trials in wound care: Reporting standards

“…[2][3][4][5][6] Nevertheless, the number of scientific publications in wound care shows a 30-fold increase over the last five decades.…”

“…3,5,8 Unfortunately, upgrading the quality of a study design does not automatically improve the quality of reporting in wound care publications. 4,9-11 First, positive study results tend to be published more often than indifferent or negative study results, known as publication bias.…”

“…[2][3][4][5][6] Nevertheless, the number of scientific publications in wound care shows a 30-fold increase over the last five decades. 7 During this period, numerous guidelines and recommendations have been developed to improve the quality of design and conduct of wound care research.…”

What Do Patients Want? Patient Preference in Wound Care

“…In the field of wound care, high-quality evidence is lacking for many of the interventions commonly utilized. 39 Even in venous ulcers, a subset of wounds with good-quality evidence and multiple CPGs, healing rates remain low. In an analysis of real-world venous ulcer care in four settings, Jones found that only some of the evidence-based practice recommendations lead to superior outcome.…”