NCT02781779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

March 10, 2023

Completed
Last Updated

March 10, 2023

Status Verified

April 1, 2020

Enrollment Period

1.5 years

First QC Date

May 20, 2016

Results QC Date

April 14, 2020

Last Update Submit

March 8, 2023

Conditions

InfectionsWounds and Injuries

Keywords

Cardiac Implantable Electronic DeviceImplant

Outcome Measures

Primary Outcomes (1)

  • 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)

    7-10 days post implant

Secondary Outcomes (5)

  • Wound Drainage

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

  • Pocket Dehiscence

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

  • Rash After Removal

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

  • Site Itching/Burning

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

  • Skin Erythema

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

Study Arms (2)

Silverlon®

ACTIVE COMPARATOR

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

Device: Silverlon®

AQUACEL® AG

ACTIVE COMPARATOR

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

Device: AQUACEL® AG

Interventions

Silverlon®DEVICE

Silverlon wound dressings

Silverlon®
AQUACEL® AGDEVICE

AQUACEL® AG wound dressings

AQUACEL® AG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

InfectionsWounds and Injuries

Results Point of Contact

Title
Donita Atkins
Organization
Kansas City Heart Rhythm Institute
donita.atkins@hcahealthcare.com
816-651-1969

Study Officials

  • Dhanunjaya Lakkireddy, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2016

First Posted

May 24, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 10, 2023

Results First Posted

March 10, 2023

Record last verified: 2020-04

Locations

US(1)