InfectionsNCT02781779
Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant
A study testing Silverlon® and AQUACEL® AG in people with Infections and Wounds and Injuries, run by Kansas City Heart Rhythm Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Wounds and Injuries
- What is being tested?
- Silverlon® and AQUACEL® AG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are scheduled for a CIED implant, generator change, or upgrade at the University of Kansas Hospital
- Able to give informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
Read the detailed 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.
- Conditions
- Infections, Wounds and Injuries
- Being tested
- Silverlon®, AQUACEL® AG
- Keywords
- Cardiac Implantable Electronic Device, Implant
- Medical subject headings
- Infections, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silverlon®Device
Silverlon wound dressings
AQUACEL® AGDevice
AQUACEL® AG wound dressings
| Study group | Role | What they receive |
|---|---|---|
| Silverlon® | Active comparator | Subjects randomized to this arm will receive Silverlon® dressing postoperative. Receives: Device: Silverlon® |
| AQUACEL® AG | Active comparator | Subjects randomized to this arm will receive AQUACEL® AG dressing postoperative. Receives: Device: AQUACEL® AG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 7-10 days post implant
Secondary outcomes (5)
Wound Drainage
Number of participants with wound drainage
Measured: 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.
Measured: At time of dressing removal, up to 10 days post operative
Rash After Removal
Number of participants with rash after dressing removal
Measured: At time of dressing removal, up to 10 days post operative
Site Itching/Burning
Number of participants with Site itching/burning
Measured: At time of dressing removal, up to 10 days post operative
Skin Erythema
Number of participants with skin erythema
Measured: At time of dressing removal, up to 10 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas City Heart Rhythm Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dhanunjaya Lakkireddy, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781779
- Sponsor's protocol ID
- STUDY00003363
- Status last verified
- Apr 2020
- First submitted
- 20 May 2016
- Last updated
- 10 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant
- ClinicalTrials.gov ID
- NCT02781779
- Acronym / sponsor ID
- STUDY00003363
- Conditions
- Infections, Wounds and Injuries
- Keywords
- Cardiac Implantable Electronic Device, Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Kansas City Heart Rhythm InstituteUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 May 2016 (estimated)
- Results
- Posted 10 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silverlon® | Active comparator | Device: Silverlon®Subjects randomized to this arm will receive Silverlon® dressing postoperative. |
| AQUACEL® AG | Active comparator | Device: AQUACEL® AGSubjects randomized to this arm will receive AQUACEL® AG dressing postoperative. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are scheduled for a CIED implant, generator change, or upgrade at the University of Kansas Hospital
- Able to give informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silverlon®Silverlon wound dressings | Device | Silverlon® |
| AQUACEL® AGAQUACEL® AG wound dressings | Device | AQUACEL® AG |
Primary outcome
Pocket Hematoma, Moderate-Severe
Time frame: 7-10 days post implant
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)
5 secondary outcomes
Wound Drainage
Time frame: At time of dressing removal, up to 10 days post operative
Pocket Dehiscence
Time frame: At time of dressing removal, up to 10 days post operative
Rash After Removal
Time frame: At time of dressing removal, up to 10 days post operative
Site Itching/Burning
Time frame: At time of dressing removal, up to 10 days post operative
Skin Erythema
Time frame: At time of dressing removal, up to 10 days post operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhanunjaya Lakkireddy, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silverlon® and AQUACEL® AG in people with Infections and Wounds and Injuries, run by Kansas City Heart Rhythm Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pocket Hematoma, Moderate-Severe (time frame: 7-10 days post implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.