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Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant

This study is currently recruiting participants.
Verified January 2017 by Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781779
First Posted: May 24, 2016
Last Update Posted: January 9, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center
  Purpose
The purpose of this study is to learn how effective each of the two dressings, Silverlon® and AQUACEL® AG, are in preventing post cardiac implantable electronic devices (CIED) procedure wound infections.

Condition Intervention Phase
Infections Wounds and Injuries Device: Silverlon® Device: AQUACEL® AG Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant

Resource links provided by NLM:


Further study details as provided by Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center:

Primary Outcome Measures:
  • Post-operative wound infections [ Time Frame: 10 days ]
    Number of post-operative wound infections


Secondary Outcome Measures:
  • Traumatic skin tears [ Time Frame: At time of dressing removal, up to 10 days post operative ]
    Count of traumatic skin tears at the time of wound dressing removal

  • Pain score of wound dressing removal [ Time Frame: At time of dressing removal, up to 10 days post operative ]
    Pain will be reported by subject using a scale. Scores on the scale range from 1 to 10.

  • Ease of removal of wound dressing [ Time Frame: At time of dressing removal, up to 10 days post operative ]
    Measured using scale completed by study team member removing wound dressing. Scores on the scale range from 1 to 5.

  • Adherence of the dressing [ Time Frame: At time of dressing removal, up to 10 days post operative ]
  • Skin breakdown [ Time Frame: At time of dressing removal, up to 10 days post operative ]
    Measured using the National Pressure Ulcer Advisory Panel Pressure Ulcer (NPUAP) States and Categories. Skin breakdown will be assigned a category/stage of I to IV.


Estimated Enrollment: 200
Study Start Date: December 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Silverlon®
Subjects randomized to this arm will receive Silverlon® dressing postoperative.
Device: Silverlon®
Silverlon wound dressings
Active Comparator: AQUACEL® AG
Subjects randomized to this arm will receive AQUACEL® AG dressing postoperative.
Device: AQUACEL® AG
AQUACEL® AG wound dressings

Detailed Description:

This is a single center, prospective, 2-arm randomized, non-blinded study. A total of 100 participants will be assigned to the Silverlon arm and 100 to the AQUACEL AG arm.

The number of procedures to implant CIED has risen in recent years. With this rise has also brought a rise in post-procedure infections. Infections will happen and there is a continued need to improve all aspects of the surgery and post-operative care. Wound coverage with appropriate dressings is one aspect that needs to be studied in CIED implant patients. Silverlon and AQUACEL AG are two options of dressings available for these patients. This study will look to see if one of the two is a better option for post-operative CIED implant patients.

  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:

  • Patients who are scheduled for a CIED implant, generator change, or upgrade at the University of Kansas Hospital
  • Able to give informed consent

Exclusion Criteria:

  • Patients who are already on antibiotics for another reasons
  • Immunocompromised patients such as those on immunosuppressant's and HIV positive patients
  • Patients who are post device explant for lead infection
  • Patients with an allergy to adhesive, silver or an allergy to the dressing(s) or their components
  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): NCT02781779


Contacts
Contact: Donita Atkins, RN (913) 588-9714 datkins2@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Principal Investigator: Dhanunjaya Lakkireddy, MD         
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
Principal Investigator: Dhanunjaya Lakkireddy, MD University of Kansas Medical Center
  More Information

Responsible Party: Dhanunjaya Lakkireddy, MD, FACC, Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02781779     History of Changes
Other Study ID Numbers: STUDY00003363
First Submitted: May 20, 2016
First Posted: May 24, 2016
Last Update Posted: January 9, 2017
Last Verified: January 2017

Keywords provided by Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center:
Cardiac Implantable Electronic Device
Implant

Additional relevant MeSH terms:
Wounds and Injuries
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents