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Aqueous oxygen peroxide treatment of VLUs in a primary care-based randomised, double-blind, placebo-controlled trial
- Source :
- Journal of Wound Care. 23:176-190
- Publication Year :
- 2014
- Publisher :
- Mark Allen Group, 2014.
-
Abstract
- 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. Declaration of interest: This work was supported by Bioquell UK Ltd, manufacturers of the BioxyQuell system. Authors P. Winter, J. Otter, N. Adams and J. Chewins are employees of Bioquell UK Ltd.
- Subjects :
- Adult
Male
medicine.medical_specialty
Nursing (miscellaneous)
Wound therapy
Placebo-controlled study
Primary care
Placebo
Venous leg ulcer
Varicose Ulcer
Placebos
Bioburden
Double blind
Double-Blind Method
Compression Bandages
medicine
Humans
Pain Management
Pain Measurement
Wound Healing
Primary Health Care
business.industry
medicine.disease
Bandages
Surgery
Oxygen
Solutions
Treatment Outcome
Anesthesia
Chronic Disease
Female
Fundamentals and skills
Wound healing
business
Subjects
Details
- ISSN :
- 20522916 and 09690700
- Volume :
- 23
- Database :
- OpenAIRE
- Journal :
- Journal of Wound Care
- Accession number :
- edsair.doi.dedup.....79398a9e51177c889a1a1d575a785630