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

K

Kansas City Heart Rhythm Institute

Status

Completed

Conditions

Infections
Wounds and Injuries

Treatments

Device: Silverlon®
Device: AQUACEL® AG

Study type

Interventional

Funder types

Other

Identifiers

NCT02781779
STUDY00003363

Details and patient eligibility

About

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.

Full 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.

Enrollment

147 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

147 participants in 2 patient groups

Silverlon®
Active Comparator group
Description:
Subjects randomized to this arm will receive Silverlon® dressing postoperative.
Treatment:
Device: Silverlon®
AQUACEL® AG
Active Comparator group
Description:
Subjects randomized to this arm will receive AQUACEL® AG dressing postoperative.
Treatment:
Device: AQUACEL® AG

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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