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Protease-Modulating Matrix Treatments for Healing Venous Leg Ulcers

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Protease-Modulating Matrix Treatments for Healing Venous Leg Ulcers The University of Manchester Research Protease-modulating matrix treatments for healing venous leg ulcers DOI: 10.1002/14651858.CD011918.pub2 10.1002/14651858.CD011918 Document Version Final published version Link to publication record in Manchester Research Explorer Citation for published version (APA): Westby, M. J., Dumville, J. C., Stubbs, N., Norman, G., & Cullum, N. (2016). Protease-modulating matrix treatments for healing venous leg ulcers. Cochrane Database of Systematic Reviews, 2015(10), [CD011918]. https://doi.org/10.1002/14651858.CD011918.pub2, https://doi.org/10.1002/14651858.CD011918 Published in: Cochrane Database of Systematic Reviews Citing this paper Please note that where the full-text provided on Manchester Research Explorer is the Author Accepted Manuscript or Proof version this may differ from the final Published version. If citing, it is advised that you check and use the publisher's definitive version. General rights Copyright and moral rights for the publications made accessible in the Research Explorer are retained by the authors and/or other copyright owners and it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights. Takedown policy If you believe that this document breaches copyright please refer to the University of Manchester’s Takedown Procedures [http://man.ac.uk/04Y6Bo] or contact [email protected] providing relevant details, so we can investigate your claim. Download date:23. Sep. 2021 Cochrane Database of Systematic Reviews Protease-modulating matrix treatments for healing venous leg ulcers (Review) Westby MJ, Norman G, Dumville JC, Stubbs N, Cullum N Westby MJ, Norman G, Dumville JC, Stubbs N, Cullum N. Protease-modulating matrix treatments for healing venous leg ulcers. Cochrane Database of Systematic Reviews 2016, Issue 12. Art. No.: CD011918. DOI: 10.1002/14651858.CD011918.pub2. www.cochranelibrary.com Protease-modulating matrix treatments for healing venous leg ulcers (Review) Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . ..... 4 BACKGROUND .................................... 6 OBJECTIVES ..................................... 8 METHODS ...................................... 8 Figure1. ..................................... 11 Figure2. ..................................... 14 Figure3. ..................................... 15 RESULTS....................................... 18 DISCUSSION ..................................... 23 AUTHORS’CONCLUSIONS . 24 ACKNOWLEDGEMENTS . 25 REFERENCES ..................................... 25 CHARACTERISTICSOFSTUDIES . 33 DATAANDANALYSES. 64 Analysis 1.1. Comparison 1 PPM dressing regimen versus other dressing regimen, Outcome 1 Proportion of participants healed(shortterm-8weeks). 65 Analysis 1.2. Comparison 1 PPM dressing regimen versus other dressing regimen, Outcome 2 Proportion of participants healed(mediumterm-12weeks).. 66 Analysis 1.3. Comparison 1 PPM dressing regimen versus other dressing regimen, Outcome 3 Proportion of participants with 1 or more adverse events at 2-12 weeks. ....... 67 Analysis 1.4. Comparison 1 PPM dressing regimen versus other dressing regimen, Outcome 4 Proportion of participants withpainat2-12weeks. 68 Analysis 1.5. Comparison 1 PPM dressing regimen versus other dressing regimen, Outcome 5 Proportion of participants withinfectionat2-12weeks. 69 Analysis 1.6. Comparison 1 PPM dressing regimen versus other dressing regimen, Outcome 6 Sensitivity analysis - available case - proportion of participants healed. ........ 70 Analysis 1.7. Comparison 1 PPM dressing regimen versus other dressing regimen, Outcome 7 Subgroup analysis: (+/-) silver - proportion of participants healed medium term. ............... 71 ADDITIONALTABLES. 72 APPENDICES ..................................... 77 CONTRIBUTIONSOFAUTHORS . 83 DECLARATIONSOFINTEREST . 83 SOURCESOFSUPPORT . 83 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . .... 84 Protease-modulating matrix treatments for healing venous leg ulcers (Review) i Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Review] Protease-modulating matrix treatments for healing venous leg ulcers Maggie J Westby1, Gill Norman1, Jo C Dumville1, Nikki Stubbs2, Nicky Cullum1 1Division of Nursing, Midwifery & Social Work, School of Health Sciences, Faculty of Biology, Medicine & Health, University of Manchester, Manchester, UK. 2Wound Prevention and Management Service, Leeds Community Healthcare NHS Trust, St Mary’s Hospital, Leeds, UK Contact address: Maggie J Westby, Division of Nursing, Midwifery & Social Work, School of Health Sciences, Faculty of Bi- ology, Medicine & Health, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, UK. [email protected]. Editorial group: Cochrane Wounds Group. Publication status and date: New, published in Issue 12, 2016. Review content assessed as up-to-date: 19 September 2016. Citation: Westby MJ, Norman G, Dumville JC, Stubbs N, Cullum N. Protease-modulating matrix treatments for healing venous leg ulcers. Cochrane Database of Systematic Reviews 2016, Issue 12. Art. No.: CD011918. DOI: 10.1002/14651858.CD011918.pub2. Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT Background Venous leg ulcers (VLUs) are open skin wounds on the lower leg that occur because of poor blood flow in the veins of the leg; leg ulcers can last from weeks to years, and are both painful and costly. Prevalence in the UK is about 2.9 cases per 10,000 people. First- line treatment for VLUs is compression therapy, but around 60% of people have unhealed ulcers after 12 weeks’ treatment and about 40% after 24 weeks; therefore, there is scope for further improvement. Limited evidence suggests non-healing leg ulcers may have persisting elevated levels of proteases, which is thought to deter the later stages of healing; thus, timely protease-modulating matrix (PMM) treatments may improve healing by physically removing proteases from the wound fluid. Objectives To determine the effects of protease-modulating matrix (PMM) treatments on the healing of venous leg ulcers, in people managed in any care setting. Search methods In September 2016 we searched: the Cochrane Wounds Specialised Register; CENTRAL; Ovid MEDLINE; Ovid MEDLINE (In- Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. Selection criteria We searched for published or unpublished randomised controlled trials (RCTs) that evaluated PMM treatments for VLUs. We defined PMM treatments as those with a purposeful intent of reducing proteases. Wound healing was the primary endpoint. Data collection and analysis Two review authors independently performed study selection, risk of bias assessment and data extraction. Protease-modulating matrix treatments for healing venous leg ulcers (Review) 1 Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Main results We included 12 studies (784 participants) in this review; sample sizes ranged from 10 to 187 participants (median 56.5). One study had three arms that were all relevant to this review and all the other studies had two arms. One study was a within-participant comparison. All studies were industry funded. Two studies provided unpublished data for healing. Nine of the included studies compared PMM treatments with other treatments and reported results for the primary outcomes. All treatments were dressings. All studies also gave the participants compression bandaging. Seven of these studies were in participants described as having ’non-responsive’ or ’hard-to-heal’ ulcers. Results, reported at short, medium and long durations and as time-to- event data, are summarised for the comparison of any dressing regimen incorporating PMM versus any other dressing regimen. The majority of the evidence was of low or very low certainty, and was mainly downgraded for risk of bias and imprecision. It is uncertain whether PMM dressing regimens heal VLUs quicker than non-PMM dressing regimens (low-certainty evidence from 1 trial with 100 participants) (HR 1.21, 95% CI 0.74 to 1.97). In the short term (four to eight weeks) it is unclear whether there is a difference between PMM dressing regimens and non-PMM dressing regimens in the probability of healing (very low-certainty evidence, 2 trials involving 207 participants). In the medium term (12 weeks), it is unclear whether PMM dressing regimens increase the probability of healing compared with non- PMM dressing regimens (low-certainty evidence from 4 trials with 192 participants) (RR 1.28, 95% CI 0.95 to 1.71). Over the longer term (6 months), it is also unclear whether there is a difference between PMM dressing regimens and non-PMM dressing regimens in the probability of healing (low certainty evidence, 1 trial, 100 participants) (RR 1.06, 95% CI 0.80 to 1.41). It is uncertain whether there is a difference in adverse events between PMM dressing regimens and non-PMM
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