Trial Outcomes & Findings for A Silver Lining in the VAD Sky (NCT NCT05163392)
NCT ID: NCT05163392
Last Updated: 2025-05-06
Results Overview
Number of driveline infection per 100 patient-months
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
2 year
Results posted on
2025-05-06
Participant Flow
25 patients were enrolled and all met inclusion criteria and were randomized to treatment or placebo
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
|
Overall Study
COMPLETED
|
14
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Silver Lining in the VAD Sky
Baseline characteristics by cohort
| Measure |
SilverD
n=14 Participants
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
|
ControlD
n=11 Participants
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
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 15 • n=5 Participants
|
45 years
STANDARD_DEVIATION 14 • n=7 Participants
|
47 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
BMI
|
28.8 kg/m2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
38.4 kg/m2
STANDARD_DEVIATION 5.1 • n=7 Participants
|
34.28 kg/m2
STANDARD_DEVIATION 7.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearNumber of driveline infection per 100 patient-months
Outcome measures
| Measure |
SilverD
n=14 Participants
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
|
ControlD
n=11 Participants
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
|
|---|---|---|
|
Driveline Infection Rate
|
0.51 infections per 100 patient-month
|
06.28 infections per 100 patient-month
|
SECONDARY outcome
Timeframe: 2 yearNumber of days to first driveline infection
Outcome measures
| Measure |
SilverD
n=14 Participants
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
|
ControlD
n=11 Participants
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
|
|---|---|---|
|
Time to First Driveline Infection
|
458 days
Interval 279.0 to 637.0
|
232 days
Interval 74.0 to 390.0
|
Adverse Events
SilverD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
ControlD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place