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Post-Operative Colonization Rates of Femoral Nerve Catheters Treated With Chlorhexidine-Impregnated Patch

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ClinicalTrials.gov Identifier: NCT01411891
Recruitment Status : Completed
First Posted : August 8, 2011
Results First Posted : June 25, 2012
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Catheter Infections
Spinal Catheter (Epidural) (Subdural); Complications, Infection or Inflammation
Intervention Device: Chlorhexidine impregnated patch (Biopatch)
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Chlorhexidine Impregnated Patch.
Hide Arm/Group Description Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site. Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
Period Title: Overall Study
Started 50 50
Completed 47 48
Not Completed 3 2
Reason Not Completed
Catheter dislodgement or loss to follow-             3             2
Arm/Group Title Control Chlorhexidine Impregnated Patch. Total
Hide Arm/Group Description Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site. Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site. Total of all reporting groups
Overall Number of Baseline Participants 47 48 95
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 48 participants 95 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
  55.3%
37
  77.1%
63
  66.3%
>=65 years
21
  44.7%
11
  22.9%
32
  33.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 48 participants 95 participants
63.5  (9.6) 61.2  (8.6) 63  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 48 participants 95 participants
Female
19
  40.4%
24
  50.0%
43
  45.3%
Male
28
  59.6%
24
  50.0%
52
  54.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants 48 participants 95 participants
47 48 95
1.Primary Outcome
Title Catheter Tip Colonization
Hide Description 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.
Time Frame 24-48 hours after placement of femoral nerve catheter.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients presenting for elective TKA.
Arm/Group Title Control Chlorhexidine Impregnated Patch.
Hide Arm/Group Description:
Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
Overall Number of Participants Analyzed 47 48
Measure Type: Number
Unit of Measure: participants
2 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Chlorhexidine Impregnated Patch.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
0.3 to 8.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Catheter Insertion Site Colonization.
Hide Description 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.
Time Frame 24-48 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Chlorhexidine Impregnated Patch.
Hide Arm/Group Description:
Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
Overall Number of Participants Analyzed 47 48
Measure Type: Number
Unit of Measure: participants
14 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Chlorhexidine Impregnated Patch.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.4 to 1.6
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Chlorhexidine Impregnated Patch.
Hide Arm/Group Description Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site. Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
All-Cause Mortality
Control Chlorhexidine Impregnated Patch.
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Chlorhexidine Impregnated Patch.
Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/48 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control Chlorhexidine Impregnated Patch.
Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/48 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kristopher Schroeder
Organization: University of Wisconsin School of Medicine and Public Health, Department of Anesthesiology
Phone: 608-263-8100
EMail: kmschro1@wisc.edu
Publications of Results:
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01411891     History of Changes
Other Study ID Numbers: 2010-0444
First Submitted: May 17, 2011
First Posted: August 8, 2011
Results First Submitted: April 20, 2012
Results First Posted: June 25, 2012
Last Update Posted: September 28, 2018