LVAD (Left Ventricular Assist Device) Driveline Infection
Conditions
Brief summary
The investigators propose to conduct a prospective randomized trail (RCT) of a driveline management protocol. The study will be initiated at UCSF from January 1st 2022 to December 31st 2022 as a pilot to be extended to other sites with the ultimate goal to develop a multi-center RCT. The driveline dressing protocol studied will include a silver-based dressing barrier as well as a dressing change protocol and material designed to reduce the risk of driveline dressing induced dermatitis and allergies. Assessment will include DLI rates, DLI speciation, dermatitis rate, comfort, ease of use, compliance and cost
Detailed description
This prospective research clinical trial will be conducted in a single academic medical center. The enrollment period will be between January 1st, 2022 and December 31st, 2023. The initial follow-up period will be closed on December 31st 2023 with a continuation of the follow-up until December 31st 2024. Patients will be selected from current LVAD patients followed by our medical center clinic and from patients implanted with LVAD at our center during the study enrollment timeframe. Patients will be randomly assigned to the control protocol and the silver protocol. Both protocols will be taught to the patients and nursing staff by the VAD coordinators. The comparative evaluation will be done through adverse event collection, driveline culture results, patient survey and DL photos at specific intervals. Interventions A new driveline dressing kit will be trialed on patients randomized to the intervention arm of the study. Both arms will have a regular dressing kit and a sensitive dressing kit. The trial arm kits include: 1. For standard dressing: a silverlon antimicrobial patch, CHG swabs for cleaning, an occlusive dressing with window, and driveline anchors. The driveline dressing change frequency will be weekly. 2. For sensitive skin dressing: a silverlon antimicrobial patch, Providone/iodine swabs for cleaning, an occlusive dressing with window, and sensitive driveline anchors. The driveline dressing change frequency will be weekly. The control arm kits include: 1. For standard dressing: No antimicrobial barrier, CHG swabs for cleaning, an occlusive dressing with window, and driveline anchors. The driveline dressing change frequency will be every 96 hours. 2. For sensitive skin dressing: No antimicrobial barrier, Providone/iodine swabs for cleaning, an occlusive dressing with window, and driveline anchors. The driveline dressing change frequency will be every 96hr.
Interventions
DEVICESilverlon
SIlver-plated biopatch
DEVICEControl
Tegaderm without biopatch
Sponsors
University of California, San Francisco
International Consortium of Circulatory Assist Clinicians
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients will be randomly assigned to one of 2 arms conducted in parallel. The trial arm kits include: 1. For standard dressing: a silverlon antimicrobial patch, CHG swabs for cleaning, an occlusive dressing with window, and driveline anchors. The driveline dressing change frequency will be weekly. 2. For sensitive skin dressing: a silverlon antimicrobial patch, Providone/iodine swabs for cleaning, an occlusive dressing with window, and sensitive driveline anchors. The driveline dressing change frequency will be weekly. The control arm kits include: 1. For standard dressing: No antimicrobial barrier, CHG swabs for cleaning, an occlusive dressing with window, and driveline anchors. The driveline dressing change frequency will be every 96 hours. 2. For sensitive skin dressing: No antimicrobial barrier, Providone/iodine swabs for cleaning, an occlusive dressing with window, and driveline anchors. The driveline dressing change frequency will be every 96hr.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* \>18 years of age * Implanted with LVAD as DT or BTT at the Academic Medical Center with implantation scheduled between January 1st, 2022 and December 31st, 2022
Exclusion criteria
* A history of DLI * A history of sternal wound infection * Implantation secondary to VAD exchange for device infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Driveline Infection Rate | 2 year | Number of driveline infection per 100 patient-months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Driveline Infection | 2 year | Number of days to first driveline infection |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLiviu Klein, MD
University of California, San Francisco
Participant flow
Recruitment details
25 patients were enrolled and all met inclusion criteria and were randomized to treatment or placebo
Participants by arm
| Arm | Count |
|---|---|
| SilverD The SIlverD arm includes:
1. For standard dressing: a silverlon antimicrobial patch, CHG swabs for cleaning, an occlusive dressing with window, and driveline anchors. The driveline dressing change frequency will be weekly.
2. For sensitive skin dressing: a silverlon antimicrobial patch, Providone/iodine swabs for cleaning, an occlusive dressing with window, and sensitive driveline anchors. The driveline dressing change frequency will be weekly.
Silverlon: SIlver-plated biopatch | 14 |
| ControlD The ControlD arm includes:
1. For standard dressing: No antimicrobial barrier, CHG swabs for cleaning, an occlusive dressing with window, and driveline anchors. The driveline dressing change frequency will be every 96 hours.
2. For sensitive skin dressing: No antimicrobial barrier, Providone/iodine swabs for cleaning, an occlusive dressing with window, and driveline anchors. The driveline dressing change frequency will be every 96hr.
Control: Tegaderm without biopatch | 11 |
| Total | 25 |
Baseline characteristics
| Characteristic | SilverD | ControlD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 10 Participants | 21 Participants |
| Age, Continuous | 50 years STANDARD_DEVIATION 15 | 45 years STANDARD_DEVIATION 14 | 47 years STANDARD_DEVIATION 14 |
| BMI | 28.8 kg/m2 STANDARD_DEVIATION 4.6 | 38.4 kg/m2 STANDARD_DEVIATION 5.1 | 34.28 kg/m2 STANDARD_DEVIATION 7.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 2 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 9 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 14 Participants | 11 Participants | 25 Participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 14 Participants | 8 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 14 | 2 / 11 |
| other Total, other adverse events | 0 / 14 | 0 / 11 |
| serious Total, serious adverse events | 0 / 14 | 0 / 11 |
Outcome results
Primary
Driveline Infection Rate
Number of driveline infection per 100 patient-months
Time frame: 2 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SilverD | Driveline Infection Rate | 0.51 infections per 100 patient-month |
| ControlD | Driveline Infection Rate | 06.28 infections per 100 patient-month |
Secondary
Time to First Driveline Infection
Number of days to first driveline infection
Time frame: 2 year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SilverD | Time to First Driveline Infection | 458 days |
| ControlD | Time to First Driveline Infection | 232 days |