Status:
COMPLETED
Clinical Trial of a Silver Eluting Dressing System
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Michael E. DeBakey VA Medical Center
Conditions:
Vascular Disease
Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 revascularization...
Detailed Description
Rationale: One of the most common post-operative complications of surgical procedures remains surgical site infection, which causes significant morbidity and healthcare costs (estimated at $1.5 billi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Age less than 18
- Known allergy to silver or alginate
- Participation in another interventional clinical trial
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01229358
Start Date
October 1 2010
End Date
December 1 2014
Last Update
January 12 2016
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
Michael Debakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030