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Clinical Trial of a Silver Eluting Dressing System (SILVER)

This study is currently recruiting participants.
Verified February 2013 by Brigham and Women's Hospital
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01229358
First received: October 26, 2010
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Wound complication [ Time Frame: Within 30 days of index procedure ] [ Designated as safety issue: No ]
    • 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)


Estimated Enrollment: 500
Study Start Date: October 2010
Estimated Study Completion Date: October 2013
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229358

Contacts
Contact: Amanda Shanner, BS 617-525-8555 ashanner@partners.org
Contact: C Keith Ozaki, MD 857-307-1920 CKOzaki@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Mary Trovato, RN     617-632-7488     mtrovato@bidmc.harvard.edu    
United States, Texas
Michael Debakey Veterans Affairs Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Neal Barshes, MD     713-794-7892     nbarshes@bcm.edu    
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:

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
Study First Received: October 26, 2010
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
vascular surgery
wound infection
wound complication

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013