N/A
N=147
Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant
Infections · Wounds and Injuries
Bottom Line
View on ClinicalTrials.gov: NCT02781779 ↗Enrolled (actual)
147
Serious AEs
—
Results posted
Mar 2023
Primary outcome: Primary: Pocket Hematoma, Moderate-Severe — 2; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Silverlon® (Device); AQUACEL® AG (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kansas City Heart Rhythm Institute
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pocket Hematoma, Moderate-Severe |
2; 2 | — |
| SECONDARY Wound Drainage |
1; 1 | — |
| SECONDARY Pocket Dehiscence |
1; 0 | — |
| SECONDARY Rash After Removal |
0; 2 | — |
| SECONDARY Site Itching/Burning |
7; 4 | — |
| SECONDARY Skin Erythema |
4; 3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02781779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.