Clinical Trial of a Silver Eluting Dressing System

Completed · Phase 4

Conditions studied: Vascular Disease, Surgery

In brief

This prospective, multi-institutional randomized clinical trial of a silver ion eluting dressing material compared to standard dry gauze for closed skin incisions after open surgical revascularizations for peripheral vascular occlusive disease. Based on the ability of the silver to lower the bacterial contamination of these vulnerable surgical skin incisions, the investigators hypothesize that immediate application of Acticoat Absorbent® as a post-operative dressing will reduce closed incisional wound complications in patients undergoing lower extremity revascularizations involving infrainguinal skin incisions compared to standard non-silver eluting dressing material.

Key facts

Study ID

NCT01229358

Run by

Brigham and Women's Hospital

People needed

500

Starts

2010-10-01

Expected to finish

2014-12-01

Last updated by the study team

2016-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patient capable of informed consent who completes consent process
• Undergoing open (an incision below inguinal ligament) surgical procedure for peripheral arterial vascular disease in which it is anticipated that the incisions will be closed. Open cases combined with endovascular approaches acceptable.

You may not qualify if…

• Age less than 18
• Known allergy to silver or alginate
• Participation in another interventional clinical trial

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Michael Debakey Veterans Affairs Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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