Randomized controlled trial and cost-effectiveness analysis of silver-donating antimicrobial dressings for venous leg ulcers (VULCAN trial)

Abstract

ISRCTN 72485131 (http://www.controlled-trials.com).

Topical Wound Oxygen Versus Conventional Compression Dressings in the Management of Refractory Venous Ulcers

“…Results from the Venous ULcer Cost-effectiveness of Antimicrobial dressings (VULCAN) trial showed that it took 101 days to heal 3-cm ulcers, while there was a 1-year recurrence rate of 14% in 86% of small ulcers [55], using silver dressings. These types of dressings are now rarely seen in a standard tertiary vein unit.…”

Efectividad del tratamiento de las úlceras venosas con vendaje compresivo multicapa asociado a protección de la piel perilesional con Cavilon® (película barrera no irritante)

“…Los resultados del estudio pusieron de manifiesto que el adecuado tratamiento de las úlceras mediante terapéutica de compresión permite una reducción media del área de las úlceras en 4 semanas de 51%, porcentaje de reducción de las úlceras que está en línea con los conseguidos en otros estudios recientes (16,19,20), lo que sería indicativo de un correcto manejo clínico y terapéutico general en ambos grupos.…”

The challenge of using randomized trials in wound healing

“…Many of the difficulties and controversies associated with using RCTs in wound healing research are highlighted by a recent publication in BJS comparing two treatment strategies in patients with venous ulceration 9 . The key elements of rigour associated with a RCT were all fulfilled.…”

“…The specific items to be included can result in an underestimation of total resource use as the analysis focuses on limited items such as dressings or visits. In the recent study 9 alluded to, the unit cost of some dressings was higher and the frequency of dressing change (analysis not included in the report) would inevitably influence cost. Items included in the analysis will clearly influence the estimate of cost.…”

“…In the case of the cited article 9 , cost analysis related to those patients who completed a EuroQol -Five Dimensions questionnaire, although the authors recognized that there was over-representation of healed patients who completed the questionnaire resulting in an underestimation of costs. This highlights the difficulty of economic analysis in the context of a RCT.…”