Aqueous oxygen peroxide treatment of VLUs in a primary care-based randomised, double-blind, placebo-controlled trial

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.

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.

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.

The addition of AOP treatment provides substantial benefits to patients with chronic venous leg ulceration compared with current best practice.