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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silverlon® | Active Comparator | Subjects randomized to this arm will receive Silverlon® dressing postoperative. |
|
| AQUACEL® AG | Active Comparator | Subjects randomized to this arm will receive AQUACEL® AG dressing postoperative. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silverlon® | Device | Silverlon wound dressings |
| |
| AQUACEL® AG |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dhanunjaya Lakkireddy, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
Immunocompromised patients and those on non-standard antibiotic regimens were excluded.
Prospectively enrolled patients undergoing CIED implantation, upgrade, or generator change from June 2016-June 2017 were randomized to receive one of the two dressings at the end of the procedure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Silverlon® | Subjects randomized to this arm will receive Silverlon® dressing postoperative. Silverlon®: Silverlon wound dressings |
| FG001 | AQUACEL® AG | Subjects randomized to this arm will receive AQUACEL® AG dressing postoperative. AQUACEL® AG: AQUACEL® AG wound dressings |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Silverlon® | Subjects randomized to this arm will receive Silverlon® dressing postoperative. Silverlon®: Silverlon wound dressings |
| BG001 | AQUACEL® AG | Subjects randomized to this arm will receive AQUACEL® AG dressing postoperative. AQUACEL® AG: AQUACEL® AG wound dressings |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Number | participants | 7-10 days post implant |
|
Adverse events were not monitored/assessed.
Adverse events were not monitored/assessed. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Silverlon® | Subjects randomized to this arm will receive Silverlon® dressing postoperative. Silverlon®: Silverlon wound dressings |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donita Atkins | Kansas City Heart Rhythm Institute | 816-651-1969 | donita.atkins@hcahealthcare.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2016 | Apr 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D014947 | Wounds and Injuries |
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| Device |
AQUACEL® AG wound dressings |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Diabetes | Count of Participants | Participants |
|
| Chronic Kidney Disease (CKD) | Count of Participants | Participants |
|
| Oral Anticoagulant (OAC) | Count of Participants | Participants |
|
| Platelets | Mean | Standard Deviation | Platelets*1000 |
|
| Serum Creatinine (Serum Cr) | Mean | Standard Deviation | mg/dL |
|
| International Normalized Ratio (INR) | The INR is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using the following formula: INR = Patient PT ÷ Control PT | Mean | Standard Deviation | Ratio |
|
Subjects randomized to this arm will receive Silverlon® dressing postoperative. Silverlon®: Silverlon wound dressings |
| OG001 | AQUACEL® AG | Subjects randomized to this arm will receive AQUACEL® AG dressing postoperative. AQUACEL® AG: AQUACEL® AG wound dressings |
|
|
| Secondary | Wound Drainage | Number of participants with wound drainage | Posted | Count of Participants | Participants | At time of dressing removal, up to 10 days post operative |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | At time of dressing removal, up to 10 days post operative |
|
|
|
| Secondary | Rash After Removal | Number of participants with rash after dressing removal | Posted | Count of Participants | Participants | At time of dressing removal, up to 10 days post operative |
|
|
|
| Secondary | Site Itching/Burning | Number of participants with Site itching/burning | Posted | Count of Participants | Participants | At time of dressing removal, up to 10 days post operative |
|
|
|
| Secondary | Skin Erythema | Number of participants with skin erythema | Posted | Count of Participants | Participants | At time of dressing removal, up to 10 days post operative |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | AQUACEL® AG | Subjects randomized to this arm will receive AQUACEL® AG dressing postoperative. AQUACEL® AG: AQUACEL® AG wound dressings | 0 | 0 | 0 | 0 | 0 | 0 |
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