Trial Outcomes & Findings for SQ53 Disinfectant Wipes for Prevention of CRBSI (NCT NCT04822467)
NCT ID: NCT04822467
Last Updated: 2023-06-02
Results Overview
Reduction in the number of CRBSI experienced by participants over a six month period (1000 days)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
6 months
Results posted on
2023-06-02
Participant Flow
Participant milestones
| Measure |
Standard Wipe
Participants will receive a supply of ethanol-based wipes for daily use
Ethanol Wipe: Ethanol-based wipe to be used by the participant daily or upon dressing change
|
SQ53 Wipe
Participants will receive a supply of SQ53 wipes for daily use.
SQ53 Wipe: SQ53-based wipe to be used by the participant daily or upon dressing change
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SQ53 Disinfectant Wipes for Prevention of CRBSI
Baseline characteristics by cohort
| Measure |
Standard Wipe
n=29 Participants
Participants will receive a supply of ethanol-based wipes for daily use
Ethanol Wipe: Ethanol-based wipe to be used by the participant daily or upon dressing change
|
SQ53 Wipe
n=30 Participants
Participants will receive a supply of SQ53 wipes for daily use.
SQ53 Wipe: SQ53-based wipe to be used by the participant daily or upon dressing change
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.7 Years
STANDARD_DEVIATION 15 • n=5 Participants
|
51.7 Years
STANDARD_DEVIATION 17.6 • n=7 Participants
|
52.2 Years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Data analysis was done on all subjects enrolled as well as those that met the protocol defined compliance rates. Subjects were removed due inability to continue with the protocol (moving to different Home Parenteral Nutrition service or not following treatment guidelines)
Reduction in the number of CRBSI experienced by participants over a six month period (1000 days)
Outcome measures
| Measure |
Standard Wipe
n=29 Participants
Participants will receive a supply of ethanol-based wipes for daily use
Ethanol Wipe: Ethanol-based wipe to be used by the participant daily or upon dressing change
|
SQ53 Wipe
n=30 Participants
Participants will receive a supply of SQ53 wipes for daily use.
SQ53 Wipe: SQ53-based wipe to be used by the participant daily or upon dressing change
|
|---|---|---|
|
Number of Catheter-Related Blood Stream Infections (CRBSI) at 6 Months
Intention to Treat
|
1.98 Infections per 1000 days with catheter
Interval 1.17 to 3.34
|
2.09 Infections per 1000 days with catheter
Interval 1.21 to 3.59
|
|
Number of Catheter-Related Blood Stream Infections (CRBSI) at 6 Months
Met Protocol Compliance Definitions
|
1.73 Infections per 1000 days with catheter
Interval 0.96 to 3.13
|
1.02 Infections per 1000 days with catheter
Interval 0.46 to 2.28
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data analysis was done on all subjects enrolled as well as those that met the protocol defined compliance rates. Subjects were removed due inability to continue with the protocol (moving to different Home Parenteral Nutrition service or not following treatment guidelines)
Reduction in catheter exchange rates by participants over 1000 days
Outcome measures
| Measure |
Standard Wipe
n=29 Participants
Participants will receive a supply of ethanol-based wipes for daily use
Ethanol Wipe: Ethanol-based wipe to be used by the participant daily or upon dressing change
|
SQ53 Wipe
n=30 Participants
Participants will receive a supply of SQ53 wipes for daily use.
SQ53 Wipe: SQ53-based wipe to be used by the participant daily or upon dressing change
|
|---|---|---|
|
Catheter Exchange Rates
Intention to Treat
|
1.41 Exchanges per 1000 days with Catheter
Interval 0.76 to 2.62
|
1.61 Exchanges per 1000 days with Catheter
Interval 0.86 to 2.98
|
|
Catheter Exchange Rates
Met Protocol Compliance Definitions
|
1.26 Exchanges per 1000 days with Catheter
Interval 0.63 to 2.52
|
0.68 Exchanges per 1000 days with Catheter
Interval 0.26 to 1.82
|
Adverse Events
Standard Wipe
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SQ53 Wipe
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Wipe
n=29 participants at risk
Participants will receive a supply of ethanol-based wipes for daily use
Ethanol Wipe: Ethanol-based wipe to be used by the participant daily or upon dressing change
|
SQ53 Wipe
n=30 participants at risk
Participants will receive a supply of SQ53 wipes for daily use.
SQ53 Wipe: SQ53-based wipe to be used by the participant daily or upon dressing change
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
1/29 • Number of events 1 • 6 months
Subject reported events
|
3.3%
1/30 • Number of events 1 • 6 months
Subject reported events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place