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OpenTrials
Completed

NCT Number: NCT02781779

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

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.

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Key information

Conditions

Infections Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silverlon®

Device

Silverlon wound dressings

Aquacel® Ag

Device

AQUACEL® AG wound dressings

Primary outcomes

  1. Pocket Hematoma, Moderate-Severe

    Time frame: 7-10 days post implant

    A pocket hematoma is an accumulation of blood in or near the surgical incision which occurs because of a defect in hemostasis such as injury to blood vessels. Pocket hematoma is associated with local discomfort, an increased risk of infection, and may require surgical intervention or lead to lengthier hospital stays.

    Mild - Ecchymosis or mild effusion in the pocket, no swelling or pain to device-pocket (watchful waiting) Moderate - Large effusion in the pocket leading to swelling and causing functional impairment or pain to device-pocket Severe - Any pocket hematoma requiring: Reoperation and/or resulting in prolongation of hospitalization (defined as extended hospitalization or rehospitalization for >24 hours, postindex surgery, primarily due to hematoma) and/or requiring interruption of OAC (defined as reversal or intentional withholding, in response to pocket hematoma, resulting in subtherapeutic anticoagulation for >24 hours)

Secondary outcomes

  1. Wound Drainage

    Time frame: At time of dressing removal, up to 10 days post operative

    Number of participants with wound drainage

  2. Pocket Dehiscence

    Time frame: At time of dressing removal, up to 10 days post operative

    Pocket (Wound) Dehiscence:

    Dehiscence is a partial or total separation of previously approximated wound edges, due to a failure of proper wound healing. It may be just the surface layer or the whole wound.This scenario typically occurs 5 to 8 days following surgery when healing is still in the early stages.

  3. Rash After Removal

    Time frame: At time of dressing removal, up to 10 days post operative

    Number of participants with rash after dressing removal

  4. Site Itching/Burning

    Time frame: At time of dressing removal, up to 10 days post operative

    Number of participants with Site itching/burning

  5. Skin Erythema

    Time frame: At time of dressing removal, up to 10 days post operative

    Number of participants with skin erythema

Sponsors and collaborators

Lead sponsor

Kansas City Heart Rhythm Institute

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 24, 2016
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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