RESUMEN
OBJECTIVE: To evaluate a novel aqueous oxygen peroxide (AOP) wound therapy (BioxyQuell) in a multi-centre, primary care-based, randomised, double-blind, placebo-controlled, parallel-group trial, monitoring long-term healing outcomes over 12 months. METHOD: Sixty-one patients with chronic, stable venous leg ulceration were treated with either AOP solution or sterile water placebo applied as a lavage over 2 weeks. The patients' wounds were dressed weekly and assessed fortnightly over the following 6 weeks. Patients who completed the initial 8-week trial were invited into a 10-month follow-up trial. The primary endpoints of the study were wound healing at 8 weeks, 12 weeks, 6 months and 12 months, and wound size reduction during the treatment phase. Secondary endpoints were reductions in wound bioburden and pain. RESULTS: Patients treated with AOP were more likely to heal at 6 months (p=0.014) and 12 months (p=0.006), but not at 8 weeks (p=0.979) or 12 weeks (p=0.263). Patients treated with AOP had greater wound area reduction (p=0.015), reductions in pain measured on a 100-point scale (p=0.001) and wound bioburden reduction (p=0.005) during the treatment phase. CONCLUSION: The addition of AOP treatment provides substantial benefits to patients with chronic venous leg ulceration compared with current best practice.
