Estimating the applicability of wound care randomized controlled trials to general wound-care populations by estimating the percentage of individuals excluded from a typical wound-care population in such trials.
OBJECTIVE
To determine the percentage of individuals that would be excluded from wound care randomized controlled trials (RCTs) as a surrogate for applicability to general populations.


METHODS
A representative sample of wound-care RCTs was selected from the literature in the past 10 years. Exclusion criteria from the trials were evaluated, and prevalence values for each excluded condition were obtained from a large wound-care population, as well as from the literature. The percentage of patients excluded on this basis was calculated.


METHODS
Seventeen RCTs testing "high-technology" wound-care products were evaluated.


METHODS
: Patients in the trials were treated for ulcers (venous, diabetic foot, and pressure ulcers).


METHODS
A percentage of patients in the study population were excluded for each RCT.


RESULTS
More than 50% of the study population would have been excluded in 15 of the 17 RCTs. When less clinically relevant exclusion criteria were removed, 14 of 17 RCTs would still have excluded between 25% and 50% of the study population.


CONCLUSIONS
The results raise serious questions regarding the applicability of these RCTs to wound-care populations.
Carter
Marissa J
MJ
Strategic Solutions, Inc, Cody, Wyoming, USA.
Fife
Caroline E
CE
Walker
David
D
Thomson
Brett
B
D006801:Humans; D018579:Patient Selection; D044382:Population Groups; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012883:Skin Ulcer / Q000628:therapy*; D014945:Wound Healing