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Clinical Trial of a Silver Eluting Dressing System (SILVER)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01229358
First Posted: October 27, 2010
Last Update Posted: January 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Beth Israel Deaconess Medical Center
Michael Debakey Veterans Affairs Medical Center
Information provided by (Responsible Party):
C. Keith Ozaki, M.D., F.A.C.S., Brigham and Women's Hospital
  Purpose
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.

Condition Intervention Phase
Vascular Disease Surgery Other: Surgical dressing Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective, Randomized Clinical Trial of a Silver Eluting Dressing System for Prevention of Lower Extremity Revascularization Wound Complications

Resource links provided by NLM:


Further study details as provided by C. Keith Ozaki, M.D., F.A.C.S., Brigham and Women's Hospital:

Primary Outcome Measures:
  • Wound complication [ Time Frame: Within 30 days of index procedure ]
    • No Wound Complication
    • Superficial Incisional SSI: Infection that occurs within 30 days after the operation and infection involves only skin/ SQ tissue of the incision
    • Deep Incisional SSI: Infection that occurs within 30 days after operation and infection appears to be related to the operation and infection involved deep tissues (fascial/muscle layers) of the incision
    • Other (seroma, lymphocele, hematoma, etc)


Enrollment: 500
Study Start Date: October 2010
Study Completion Date: December 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Silver Eluting Dressing
Acticoat Absorbant™ applied as post-operative dressing
Other: Surgical dressing
Acticoat Absorbant™ vs standard dry gauze as the immediate post operative dressing
Other Name: Acticoat Absorbant™, Silver dressing
Active Comparator: Standard Guaze
Standard dry gauze applied as post-operative dressing
Other: Surgical dressing
Acticoat Absorbant™ vs standard dry gauze as the immediate post operative dressing
Other Name: Acticoat Absorbant™, Silver dressing

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • Age less than 18
  • Known allergy to silver or alginate
  • Participation in another interventional clinical trial
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229358


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Texas
Michael Debakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Michael Debakey Veterans Affairs Medical Center
Investigators
Principal Investigator: C Keith Ozaki, MD Brigham and Women's Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: C. Keith Ozaki, M.D., F.A.C.S., Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01229358     History of Changes
Other Study ID Numbers: 2010-P-001149/1
First Submitted: October 26, 2010
First Posted: October 27, 2010
Last Update Posted: January 12, 2016
Last Verified: January 2016

Keywords provided by C. Keith Ozaki, M.D., F.A.C.S., Brigham and Women's Hospital:
vascular surgery
wound infection
wound complication

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases