Clinical Trial of a Silver Eluting Dressing System (SILVER)

January 11, 2016 updated by: C. Keith Ozaki, M.D., F.A.C.S., Brigham and Women's Hospital

Prospective, Randomized Clinical Trial of a Silver Eluting Dressing System for Prevention of Lower Extremity Revascularization Wound Complications

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 billion per year) among hospitalized patients. Surgical wounds for lower extremity revascularization are particularly prone to infection and dehiscence, with rates in some series as high as 44%(Kent, Bartek et al. 1996). Currently, the Guideline for Prevention of Surgical Site Infection recommends the use of sterile dressing to protect closed incisions for 24 to 48 hour postoperatively. However, no evidence-based recommendations are made with regards to dressing types for use in post-operative incision care.

A plethora of wound dressings are available in the market, with silver-based dressing among these recent innovations. Topical silver treatment is an effective bactericidal agent that does not induce bacterial resistance when used in therapeutic levels. Acticoat Absorbent®(Smith and Nephew, Inc.), an antimicrobial barrier dressing is coated with nanocrystalline silver that delivers a controlled, sustained (up to three days) dose of silver ions. Additionally, this dressing absorbs moisture (minimizing wound maceration), and is safe and effective against a broad range of microorganisms. Acticoat Absorbent® (Acticoat) is indicated for surgical wounds, chronic wounds, and burn wounds; however, data are lacking regarding in its potential role in postoperative surgical incision wound infection prophylaxis.

The Principal Investigator recently completed a non-concurrent, single-institution study of patients who received conventional non-silver containing dressing with Acticoat as post-operative dressing following defined lower extremity revascularizations(Childress, Berceli et al. 2007). The study population comprised 216 patients who underwent 248 cases that met inclusion criteria. Both groups were similar with regards to age at the time of first procedure, gender, race, diabetes, hypertension, current smoking, and renal insufficiency (creatinine >1.5 mg/L). Furthermore, both groups had tissue loss as the most common indication for the lower extremity revascularization procedure, with 47% (55/118) for the control group and 38% (49/130) for the treatment group. Moreover, autogenous vein bypass graft was the most common procedure performed for the control (65/118, 55% of procedures) and treatment (54/130, 42% of procedures) groups.

The surgeons and other providers found the dressing regimen easy to apply and care for post-operatively. Revascularization pulses could be palpated through the dressing, and the low profile permitted identification of post-operative soft tissue changes such as hematomas. Compressive ace bandages could be applied without disturbing the original dressing.

Regarding the primary findings, no substantial dressing material specific complications were noted, including no apparent allergic reactions. The wound complication rate for the control group was 14% (17/118), and for the treatment group was 5% (7/130). Over the intervention phase, the wound overall complication rate fell by 64% (c2 = 5.76, df = 1, p = 0.016).

These findings provide clinical evidence that an Acticoat based dressing system offers a potentially efficacious, cost-effective adjunct to reduce surgical site infections for lower extremity revascularization. Based on this data, we believe that further investigation via multi-center randomized clinical trial is warranted. Thus for the current proposal we hypothesize that immediate application of Acticoat Absorbent® as a post-operative dressing would reduce closed incisional wound complications in patients undergoing lower extremity revascularizations involving infrainguinal skin incisions will result in a clinically significant reduction in wound complication rates compared to standard non-silver eluting dressing material.

Procedure:

  • Patient randomized in OR after wound closure completed
  • Wound closure technique at the discretion of the surgeon (Dermabond is a dressing and can not be utilized)
  • Final OR dressing is test (silver vs standard) dressing, secured per surgeon preference
  • Original OR dressing stays in place until gross soiling impairs standard wound hygiene, clinical need to remove, or POD#3, whichever comes first
  • Subsequent dressings, wound care at the discretion of providers
  • Visual wound checks at least at 2 and 4 weeks (+/- 5 days)

Clinical, economic, patient quality of life, and resource utilization data is then collected at standard clinical encounters

Primary Endpoint: Any wound complication within 30 days

Power and Sample Size Calculations:

  • Current endpoint rate at least 25%(Kent, Bartek et al. 1996; Nguyen, Brahmanandam et al. 2007)
  • Anticipate 10% absolute (40% relative) wound complication rate reduction(Childress, Berceli et al. 2007)
  • Power 0.8
  • alpha 0.05
  • control event rate of 0.25
  • treatment event rate of 0.15
  • 1:1 randomization
  • -->total study sample size 250 per group (500 total).

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Michael Debakey Veterans Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Acticoat Absorbant™, Silver dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Within 30 days of index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Beth Israel Deaconess Medical Center
Michael E. DeBakey VA Medical Center

Investigators

  • Principal Investigator: C Keith Ozaki, MD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 26, 2010

First Submitted That Met QC Criteria

October 26, 2010

First Posted (Estimate)

October 27, 2010

Study Record Updates

Last Update Posted (Estimate)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-P-001149/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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