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® & 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 random...

Full description

Bibliographic Details
Main Authors: Moffatt, Christine J., Stanton, Julie, Murray, Susie, Doody, Veronica, Davis, Paul J., Franks, Peter J.
Format: Article
Published: Elsevier 2014
Subjects:
Online Access:https://eprints.nottingham.ac.uk/38670/
_version_ 1848795664755982336
author Moffatt, Christine J.
Stanton, Julie
Murray, Susie
Doody, Veronica
Davis, Paul J.
Franks, Peter J.
author_facet Moffatt, Christine J.
Stanton, Julie
Murray, Susie
Doody, Veronica
Davis, Paul J.
Franks, Peter J.
author_sort Moffatt, Christine J.
building Nottingham Research Data Repository
collection Online Access
description This study was to evaluate the potential benefits of two products (Oxyzyme® & 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 (£5,031). When those with high protease activity the cost in the active group dominated, with lower cost (-£2,450) and an improved outcome (29 more ulcer free weeks). Health related quality of life (HRQoL) and pain significantly improved over the assessment period, though there was no difference between the treatment groups. The use of Oxyzyme® & Iodozyme®) could provide better value for money in the management of venous and mixed arterio-venous ulcers than standard care in a community leg ulcer service.
first_indexed 2025-11-14T19:35:41Z
format Article
id nottingham-38670
institution University of Nottingham Malaysia Campus
institution_category Local University
last_indexed 2025-11-14T19:35:41Z
publishDate 2014
publisher Elsevier
recordtype eprints
repository_type Digital Repository
spelling nottingham-386702020-05-04T16:54:39Z https://eprints.nottingham.ac.uk/38670/ 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 Moffatt, Christine J. Stanton, Julie Murray, Susie Doody, Veronica Davis, Paul J. Franks, Peter J. This study was to evaluate the potential benefits of two products (Oxyzyme® & 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 (£5,031). When those with high protease activity the cost in the active group dominated, with lower cost (-£2,450) and an improved outcome (29 more ulcer free weeks). Health related quality of life (HRQoL) and pain significantly improved over the assessment period, though there was no difference between the treatment groups. The use of Oxyzyme® & Iodozyme®) could provide better value for money in the management of venous and mixed arterio-venous ulcers than standard care in a community leg ulcer service. Elsevier 2014-09-03 Article PeerReviewed Moffatt, Christine J., Stanton, Julie, Murray, Susie, Doody, Veronica, Davis, Paul J. and Franks, Peter J. (2014) 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. Wound Medicine, 6 . pp. 1-10. ISSN 2213-9095 Leg ulceration Cost effectiveness Oxyzyme Iodozyme Healing Health related quality of life http://www.sciencedirect.com/science/article/pii/S2213909514000421 doi:10.1016/j.wndm.2014.08.002 doi:10.1016/j.wndm.2014.08.002
spellingShingle Leg ulceration
Cost effectiveness
Oxyzyme
Iodozyme
Healing
Health related quality of life
Moffatt, Christine J.
Stanton, Julie
Murray, Susie
Doody, Veronica
Davis, Paul J.
Franks, Peter J.
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Leg ulceration
Cost effectiveness
Oxyzyme
Iodozyme
Healing
Health related quality of life
url https://eprints.nottingham.ac.uk/38670/
https://eprints.nottingham.ac.uk/38670/
https://eprints.nottingham.ac.uk/38670/