VenUS II: A randomised controlled trial of larval therapy in the management of leg ulcers

摘要: OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of larval therapy with a standard debridement technique (hydrogel). DESIGN: A pragmatic, three-arm, randomised controlled trial an economic evaluation. SETTING: Community nursing services, community leg ulcer clinics hospital outpatient clinics. range urban rural settings. PARTICIPANTS: Patients venous or mixed venous/arterial ulcers (minimum ankle brachial pressure index 0.6) where minimum 25% area was covered by slough and/or necrotic material. INTERVENTIONS: Loose bagged compared hydrogel. MAIN OUTCOME MEASURES: The primary end point complete healing largest eligible ulcer. outcome time to reference Secondary outcomes were: debridement, cost treatments, health-related quality life (including ulcer-related pain), bacterial load, presence methicillin-resistant Staphylococcus aureus staff patient attitudes beliefs about therapy. RESULTS: Between July 2004 May 2007 recruited 267 people aged 20-94 years at entry. There were more female (n = 158) than male 109) participants most classified nurse as having greater 5 cm(2). for three treatment arms using log rank test. difference in treatments not statistically significant 5% level. Adjustment then made stratification prespecified prognostic factors (centre, baseline area, duration type ulcer) Cox proportional hazards model. No found rates between loose larvae groups. Results (loose pooled) hydrogel showed no evidence healing. When same analytical steps used investigate larvae-treated debrided significantly rapidly hydrogel-treated ulcers; however, significant. adjusted analysis reported hazard debriding any those groups approximately twice that group. differences bacteriology observed arms. Larval associated pain Our base-case evaluation large decision uncertainty hydrogel, suggesting have similar costs effects sloughy ulcers. CONCLUSIONS: reduced necrotic, chronic ulcers, hydrogel; did increase rate It impossible distinguish terms cost-effectiveness. Future research should association value patients clinicians. inform decision-makers' selection agents is goal, analytic modelling all alternative required. TRIAL REGISTRATION: Current Controlled Trials ISRCTN55114812.