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Published 19 March 2009, doi:10.1136/bmj.b825
Cite this as: BMJ 2009;338:b825
Marta O Soares, research fellow1, Cynthia P Iglesias, senior research fellow1, J Martin Bland, professor of health statistics1, Nicky Cullum, professor, deputy head of department1, Jo C Dumville, research fellow1, E Andrea Nelson, reader in wound healing and director of research2, David J Torgerson, professor, director York trials unit1, Gill Worthy, trial statistician1, on behalf of the VenUS II team
1 Department of Health Sciences, University of York, York YO10 5DD, 2 School of Healthcare, University of Leeds, UK
Correspondence to: M O Soares ms602{at}york.ac.uk
Design Cost effectiveness and cost utility analyses carried out alongside a pragmatic multicentre, randomised, open trial with equal randomisation.
Population Intention to treat population comprising 267 patients with a venous or mixed venous and arterial ulcers with at least 25% coverage of slough or necrotic tissue.
Interventions Patients were randomly allocated to debridement with bagged larvae, loose larvae, or hydrogel.
Main outcome measure The time horizon was 12 months and costs were estimated from the UK National Health Service perspective. Cost effectiveness outcomes are expressed in terms of incremental costs per ulcer-free day (cost effectiveness analysis) and incremental costs per quality adjusted life years (cost utility analysis).
Results The larvae arms were pooled for the main analysis. Treatment with larval therapy cost, on average, £96.70 (
109.61; $140.57) more per participant per year (95% confidence interval –£491.9 to £685.8) than treatment with hydrogel. Participants treated with larval therapy healed, on average, 2.42 days before those in the hydrogel arm (95% confidence interval –0.95 to 31.91 days) and had a slightly better health related quality of life, as the annual difference in QALYs was 0.011 (95% confidence interval –0.067 to 0.071). However, none of these differences was statistically significant. The incremental cost effectiveness ratio for the base case analysis was estimated at £8826 per QALY gained and £40 per ulcer-free day. Considerable uncertainty surrounds the outcome estimates.
Conclusions Debridement of sloughy or necrotic leg ulcers with larval therapy is likely to produce similar health benefits and have similar costs to treatment with hydrogel.
Trial registration Current Controlled Trials ISRCTN55114812 [controlled-trials.com] and National Research Register N0484123692.
© Soares et al 2009
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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