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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD

NCT01043705

Cardiac Implantable Electronic Device Infection

COMPLETED

Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation

NCT01841242

Heart Failure Arrhythmia

COMPLETED PHASE4

Study to Characterize Atrial Fibrillation in CHF Patients Indicated for CRT

NCT00156728

Congestive Heart Failure, Atrial Fibrillation

COMPLETED PHASE4

Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads

NCT02071173

Cardiac Resynchronization Therapy

COMPLETED NA

Determination of Risk Factors of Ventricular Arrhythmias (VAs) After Implantation of Continuous Flow Left Ventricular Assist Device With Continuous Flow Left Ventricular Assist Device (CF-LVAD)

NCT02873169

Severe Cardiac Insufficiency

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infections Wounds and Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Silverlon®

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

Group Type ACTIVE_COMPARATOR

Silverlon®

Intervention Type DEVICE

Silverlon wound dressings

AQUACEL® AG

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

Group Type ACTIVE_COMPARATOR

AQUACEL® AG

Intervention Type DEVICE

AQUACEL® AG wound dressings

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Silverlon®

Silverlon wound dressings

Intervention Type DEVICE

AQUACEL® AG

AQUACEL® AG wound dressings

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No