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

Eliot N. Mostow, G. Davin Haraway, Michael Dalsing, Jason P. Hodde, Dennis King

Research output: Contribution to journalArticle

222 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)837-843
Number of pages7
JournalJournal of Vascular Surgery
Volume41
Issue number5
DOIs
StatePublished - May 2005

Fingerprint

Leg Ulcer
Extracellular Matrix
Randomized Controlled Trials
Small Intestine
Transplants
Wounds and Injuries
Ulcer
Biocompatible Materials
Therapeutics
Recurrence
Varicose Ulcer
poly(divinyl-co-N-vinylpyrrolidinone)
Multicenter Studies
Swine
Economics
Quality of Life
Outcome Assessment (Health Care)
Morbidity

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery

Cite this

Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers : A randomized clinical trial. / Mostow, Eliot N.; Haraway, G. Davin; Dalsing, Michael; Hodde, Jason P.; King, Dennis.

In: Journal of Vascular Surgery, Vol. 41, No. 5, 05.2005, p. 837-843.

Research output: Contribution to journalArticle

@article{8e5802385d3f479d81a4bfd15f439b7d,
title = "Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: A randomized clinical trial",
abstract = "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.",
author = "Mostow, {Eliot N.} and Haraway, {G. Davin} and Michael Dalsing and Hodde, {Jason P.} and Dennis King",
year = "2005",
month = "5",
doi = "10.1016/j.jvs.2005.01.042",
language = "English",
volume = "41",
pages = "837--843",
journal = "Journal of Vascular Surgery",
issn = "0741-5214",
publisher = "Mosby Inc.",
number = "5",

}

TY - JOUR

T1 - Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers

T2 - A randomized clinical trial

AU - Mostow, Eliot N.

AU - Haraway, G. Davin

AU - Dalsing, Michael

AU - Hodde, Jason P.

AU - King, Dennis

PY - 2005/5

Y1 - 2005/5

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=18844443478&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=18844443478&partnerID=8YFLogxK

U2 - 10.1016/j.jvs.2005.01.042

DO - 10.1016/j.jvs.2005.01.042

M3 - Article

C2 - 15886669

AN - SCOPUS:18844443478

VL - 41

SP - 837

EP - 843

JO - Journal of Vascular Surgery

JF - Journal of Vascular Surgery

SN - 0741-5214

IS - 5

ER -