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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Silverlon®

AQUACEL® AG

About this trial

This is an interventional prevention trial for Infections focused on measuring Cardiac Implantable Electronic Device, Implant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Silverlon®

AQUACEL® AG

Arm Description

Subjects randomized to this arm will receive Silverlon® dressing postoperative.

Subjects randomized to this arm will receive AQUACEL® AG dressing postoperative.

Outcomes

Primary Outcome Measures

Pocket Hematoma, Moderate-Severe

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 Outcome Measures

Wound Drainage

Number of participants with wound drainage

Pocket Dehiscence

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.

Rash After Removal

Number of participants with rash after dressing removal

Site Itching/Burning

Number of participants with Site itching/burning

Skin Erythema

Number of participants with skin erythema

Full Information

NCT ID

NCT02781779

First Posted

May 20, 2016

Last Updated

March 8, 2023

Sponsor

Kansas City Heart Rhythm Institute

1. Study Identification

Unique Protocol Identification Number

NCT02781779

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

June 2016 (Actual)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kansas City Heart Rhythm Institute

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infections, Wounds and Injuries

Keywords

Cardiac Implantable Electronic Device, Implant

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

147 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Silverlon®

Arm Type

Active Comparator

Arm Description

Subjects randomized to this arm will receive Silverlon® dressing postoperative.

Arm Title

AQUACEL® AG

Arm Type

Active Comparator

Arm Description

Subjects randomized to this arm will receive AQUACEL® AG dressing postoperative.

Intervention Type

Device

Intervention Name(s)

Silverlon®

Intervention Description

Silverlon wound dressings

Intervention Type

Device

Intervention Name(s)

AQUACEL® AG

Intervention Description

AQUACEL® AG wound dressings

Primary Outcome Measure Information:

Title

Pocket Hematoma, Moderate-Severe

Description

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)

Time Frame

7-10 days post implant

Secondary Outcome Measure Information:

Title

Wound Drainage

Description

Number of participants with wound drainage

Time Frame