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Text
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<a href="http://doi.org/10.1016/j.jvs.2005.01.042" target="_blank" rel="noreferrer noopener">http://doi.org/10.1016/j.jvs.2005.01.042</a>
Pages
837–843
Issue
5
Volume
41
Dublin Core
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Title
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Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial.
Publisher
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Journal of vascular surgery
Date
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2005
2005-05
Subject
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*Biological Dressings; *Extracellular Matrix; 80 and over; Adult; Aged; Chronic Disease; Cross-Over Studies; Female; Follow-Up Studies; Humans; Leg Ulcer/pathology/*therapy; Male; Middle Aged; Prospective Studies; Treatment Outcome; Wound Healing/physiology
Creator
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Mostow Eliot N; Haraway G Davin; Dalsing Michael; Hodde Jason P; King Dennis
Description
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BACKGROUND: Venous leg ulcers are a major cause of morbidity, economic loss, and decreased quality of life in affected patients. Recently, biomaterials derived from natural tissue sources have been used to stimulate wound closure. One such biomaterial obtained from porcine small-intestine submucosa (SIS) has shown promise as an effective treatment to manage full-thickness wounds. Our objective was to compare the effectiveness of SIS wound matrix with compression vs compression alone in healing chronic leg ulcers within 12 weeks. METHODS: This was a prospective, randomized, controlled multicenter trial. Patients were 120 patients with at least 1 chronic leg ulcer. Patients were randomly assigned to receive either weekly topical treatment of SIS plus compression therapy (n = 62) or compression therapy alone (n = 58). Ulcer size was determined at enrollment and weekly throughout the treatment. Healing was assessed weekly for up to 12 weeks. Recurrence after 6 months was recorded. The primary outcome measure was the proportion of ulcers healed in each group at 12 weeks. RESULTS: After 12 weeks of treatment, 55% of the wounds in the SIS group were healed, as compared with 34% in the standard-care group (P = .0196). None of the healed patients treated with SIS wound matrix and seen for the 6-month follow-up experienced ulcer recurrence. CONCLUSIONS: The SIS wound matrix, as an adjunct therapy, significantly improves healing of chronic leg ulcers over compression therapy alone.
Identifier
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<a href="http://doi.org/10.1016/j.jvs.2005.01.042" target="_blank" rel="noreferrer noopener">10.1016/j.jvs.2005.01.042</a>
Rights
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Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
*Biological Dressings
*Extracellular Matrix
2005
80 and over
Adult
Aged
Chronic Disease
Cross-Over Studies
Dalsing Michael
Female
Follow-Up Studies
Haraway G Davin
Hodde Jason P
Humans
Journal of vascular surgery
King Dennis
Leg Ulcer/pathology/*therapy
Male
Middle Aged
Mostow Eliot N
Prospective Studies
Treatment Outcome
Wound Healing/physiology