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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infections, Wounds and Injuries

Intervention / Treatment
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* Device: Silverlon®
* Device: AQUACEL® AG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Silverlon®<br>Subjects randomized to this arm will receive Silverlon® dressing postoperative. | Device: Silverlon®<br>* Silverlon wound dressings<br>|
| Active Comparator: AQUACEL® AG<br>Subjects randomized to this arm will receive AQUACEL® AG dressing postoperative. | Device: AQUACEL® AG<br>* AQUACEL® AG wound dressings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Drainage | Number of participants with wound drainage | At time of dressing removal, up to 10 days post operative | 
| 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. | At time of dressing removal, up to 10 days post operative | 
| Rash After Removal | Number of participants with rash after dressing removal | At time of dressing removal, up to 10 days post operative | 
| Site Itching/Burning | Number of participants with Site itching/burning | At time of dressing removal, up to 10 days post operative | 
| Skin Erythema | Number of participants with skin erythema | At time of dressing removal, up to 10 days post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implant, Cardiac Implantable Electronic Device