Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: A randomized clinical trial

被引:278
作者
Mostow, EN
Haraway, GD
Dalsing, M
Hodde, JP
King, D
机构
[1] NE Ohio Univ, Coll Med, Akron Gen Med Ctr, Akron, OH USA
[2] NE Ohio Univ, Coll Med, Dept Dermatol, Akron, OH USA
[3] Case Western Reserve Univ, Coll Med, Cleveland, OH 44106 USA
[4] Oklahoma State Univ, Ctr Hlth Sci, Stillwater, OK 74078 USA
[5] Tulsa Wound Care Clin, Tulsa, OK USA
[6] Indiana Univ, Ctr Med, Indianapolis, IN 46204 USA
[7] Cook Biotech Inc, W Lafayette, IN USA
[8] STATKING Consulting Inc, Fairfield, OH USA
关键词
D O I
10.1016/j.jvs.2005.01.042
中图分类号
R61 [外科手术学];
学科分类号
摘要
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. Metbods. This was a prospective, randomized, controlled multicenter trial. Patients were 120 patients with at least I 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.
引用
收藏
页码:837 / 843
页数:7
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