A randomised trial to compare the performance of Oxyzyme® and Iodozyme® with standard care in the treatment of patients with venous and mixed venous/arterial ulceration

This study was to evaluate the potential benefits of two products (Oxyzyme® and Iodozyme®) into a leg ulcer service in South Staffordshire, UK. A randomised controlled trial (RCT) was used to evaluate time to ulcer healing, quality of life, pain and cost effectiveness. 100 patients were randomised to receive either Oxyzyme/Iodozyme (active group) or standard care (control group) with venous or mixed arterio-venous ulcers. Patients were evaluated weekly up to 12 weeks, with further follow up at 24 weeks. Whilst there was a small benefit in terms of healing over follow up using the Cox Proportional Hazards Model, this did not achieve a standard level of statistical significance (hazard ratio=1.13, 95%CI 0.64 to 2.02, p =0.67) after adjustment for confounding factors. Patients with high protease activity showed an improved and faster healing in the active group, (HR=1.35, 95%CI 0.63, 2.87) p =0.44. The active group required significantly fewer dressing changes (14.8 versus 10.0, p =0.033). Despite the dressing costs being higher, there was a significantly lower cost of nursing time, leading to a greater cost effectiveness in terms of cost per healed ulcer (£977 versus £1071. A Markov model used to assess cost effectiveness in the main trial found that the control group had slightly better outcomes (12 more ulcer free weeks), but at a substantially greater cost (£5031). When those with high protease activity the cost in the active group dominated, with lower cost (−£2450)...
Source: Wound Medicine - Category: Journals (General) Source Type: research