VenUS I: a randomised controlled trial of two types of bandage for treating venous leg ulcers
Iglesias C, Nelson EA, Cullum NA, Torgerson DJ, on behalf of the VenUS Team
Record ID 32004000652
To compare the clinical and cost-effectiveness of two different compression bandages for the healing of venous leg ulcers.
Authors' results and conclusions: A total of 387 people were recruited to the trial between April 1999 and December 2000; this represents 39% (387/988) of those approached. Patients ranged in age from 23 to 97 years at trial entry, with a mean age of 71 years. Most frequent reasons for exclusion from the trial were patients not suitable for compression, ankle/brachial pressure index lower than 0.8, diabetes mellitus and maximum ulcer <1 cm. The majority of patients in this trial (82%; 316/387) had a reference ulcer of area =10 cm2. To test the difference over time of KaplanMeier curves for the two bandage groups, the distribution of the cumulative times to healing of individuals in the two trial groups was compared using the log-rank test. The difference in the distribution of cumulative healing times between the individuals in the two groups was not statistically significant at the 5% level (log rank = 2.46, p = 0.12). Adjusting for the effects of variables which may influence healing (centre, baseline ulcer area, duration, episodes, ankle mobility, weight) in a Cox proportional hazards model, a statistically significant treatment effect in favour of the 4LB was identified. At any point in time, the probability of healing for individuals in the SSB treatment arm is significantly lower than that for people treated with the 4LB (hazard ratio 0.72, 95% confidence interval 0.58 to 0.91). Our base case economic analysis showed that the 4LB is the dominant strategy, that is, it is associated with a greater health benefit and lower costs than the SSB, although the differences are not statistically significant. This result is explained largely by the greater number of community nurse visits required by participants in the short-stretch arm.
Authors' recommendations: The 4LB, which is currently the UK standard compression bandage for people with venous leg ulcers, was more clinically and cost-effective than the SSB.
Authors' methods: Randomised controlled trial, Economic evaluation
Project Status: Completed
URL for project: http://www.hta.ac.uk/1076
Year Published: 2004
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England, United Kingdom
- Leg Ulcer
- Varicose Ulcer
- Wound Healing
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
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Copyright: 2009 Queen's Printer and Controller of HMSO
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