Trial Outcomes & Findings for Post-Operative Colonization Rates of Femoral Nerve Catheters Treated With Chlorhexidine-Impregnated Patch (NCT NCT01411891)
NCT ID: NCT01411891
Last Updated: 2018-09-28
Results Overview
Three cm of the for research purposes only, a 3 cm distal portion will be cut using sterile scissors into a sterile container, and sent to the lab for culture in a sterile container. The catheter segments will be rolled onto blood agar plates at 35°C under aerobic and anaerobic conditions. Number of colonies will be counted at 1 week. The peripheral nerve catheter tip will be considered colonized if the culture yields 15 or greater colony forming units.
COMPLETED
PHASE4
100 participants
24-48 hours after placement of femoral nerve catheter.
2018-09-28
Participant Flow
Participant milestones
| Measure |
Control
Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
|
Chlorhexidine Impregnated Patch.
Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
47
|
48
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Control
Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
|
Chlorhexidine Impregnated Patch.
Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
|
|---|---|---|
|
Overall Study
Catheter dislodgement or loss to follow-
|
3
|
2
|
Baseline Characteristics
Post-Operative Colonization Rates of Femoral Nerve Catheters Treated With Chlorhexidine-Impregnated Patch
Baseline characteristics by cohort
| Measure |
Control
n=47 Participants
Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
|
Chlorhexidine Impregnated Patch.
n=48 Participants
Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
61.2 years
STANDARD_DEVIATION 8.6 • n=107 Participants
|
63 years
STANDARD_DEVIATION 9.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=99 Participants
|
48 participants
n=107 Participants
|
95 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24-48 hours after placement of femoral nerve catheter.Population: Patients presenting for elective TKA.
Three cm of the for research purposes only, a 3 cm distal portion will be cut using sterile scissors into a sterile container, and sent to the lab for culture in a sterile container. The catheter segments will be rolled onto blood agar plates at 35°C under aerobic and anaerobic conditions. Number of colonies will be counted at 1 week. The peripheral nerve catheter tip will be considered colonized if the culture yields 15 or greater colony forming units.
Outcome measures
| Measure |
Control
n=47 Participants
Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
|
Chlorhexidine Impregnated Patch.
n=48 Participants
Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
|
|---|---|---|
|
Catheter Tip Colonization
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 24-48 hours.Skin at the FNC insertion site will be swabbed with a sterile cotton tip applicator moistened with sterile normal saline. The swab will be placed in a sterile container. The swab will be inoculated onto a blood agar plate/eosin-methylene blue plate/chocolate agar plate and incubated for 3 days aerobically, then inoculated onto an anaerobic brucella-agar plate and incubated for 7 days anaerobically. Bacterial growth found in the first quadrant of the inoculated plate will be defined as low grade, in the second and/or third will be moderate, and in the fourth quadrant will be heavy.
Outcome measures
| Measure |
Control
n=47 Participants
Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
|
Chlorhexidine Impregnated Patch.
n=48 Participants
Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
|
|---|---|---|
|
Catheter Insertion Site Colonization.
|
14 participants
|
12 participants
|
Adverse Events
Control
Chlorhexidine Impregnated Patch.
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kristopher Schroeder
University of Wisconsin School of Medicine and Public Health, Department of Anesthesiology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place