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


METHODS
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.


CONCLUSIONS
The addition of AOP treatment provides substantial benefits to patients with chronic venous leg ulceration compared with current best practice.
MRCS, FRCGP, The Gratton Surgery, Sutton Scotney, Winchester, UK.
P D
PD
O'Halloran
RGN, Bioquell UK Ltd, Andover; UK.
P K
PK
Winter
PhD, Bioquell UK Ltd, Andover; UK. Centre for Clinical Infection and Diagnostics Research (CIDR), Department of Infectious Diseases, Kings College London and Guys & St Thomas NHS Trust, London, UK.
J A
JA
Otter
BSc, Bioquell UK Ltd, Andover; UK.
N M T
NM
Adams
MBS, Bioquell UK Ltd, Andover; UK.
J
J
Chewins
D000328:Adult; D001458:Bandages; D002908:Chronic Disease; D058128:Compression Bandages; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010100:Oxygen / Q000627:therapeutic use*; D059408:Pain Management; D010147:Pain Measurement; D010919:Placebos; D011320:Primary Health Care; D012996:Solutions; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000188:drug therapy*; D014945:Wound Healing
D010919:Placebos; D012996:Solutions; D010100:Oxygen