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

Primary Purpose

Catheter Infections, Spinal Catheter (Epidural) (Subdural); Complications, Infection or Inflammation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine impregnated patch (Biopatch)
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Catheter Infections focused on measuring Arthroplasty, Infection Control

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients age 18-85 undergoing elective knee arthroplasty who elect to have a femoral nerve block catheter placed for postoperative analgesia.

Exclusion Criteria:

  • Allergy to local anesthetics,
  • local or generalized infection or inflammation,
  • current antibiotic therapy,
  • immunocompromised patients,
  • a history of chronic steroid use,
  • neurological deficits,
  • pregnancy,
  • prisoners,
  • refusal to participate,
  • primary language other than English,
  • and patients currently participating in a study.

Sites / Locations

  • University of Wisconsin School of Medicine and Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Chlorhexidine impregnated patch.

Arm 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.

Outcomes

Primary Outcome Measures

Catheter Tip Colonization
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.

Secondary Outcome Measures

Catheter Insertion Site Colonization.
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.

Full Information

First Posted
May 17, 2011
Last Updated
August 30, 2018
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT01411891
Brief Title
Post-Operative Colonization Rates of Femoral Nerve Catheters Treated With Chlorhexidine-Impregnated Patch
Official Title
Prospective Randomized Control Trial of Post-Operative Colonization Rates of Femoral Nerve Catheters With the Use of Chlorhexidine-Impregnated Patch
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Joint replacement is becoming an increasingly common procedure. In 2005, 534,000 total knee arthroplasties (TKA) were performed in the United States which is at a rate of 18.1 per 10,000 individuals, and the demand for primary TKA is projected to grow by 673% by 2030. Effective post-operative analgesia is an important component with regards to patient satisfaction and hospital stay. Regional anesthesia has been shown to decrease duration of surgery, need for transfusion, post-operative nausea and vomiting, and the incidence of thromboembolic disease in patients undergoing total knee or total hip replacement when compared with general anesthesia. Post-operatively, regional anesthesia has been shown to reduce pain scores and/or morphine consumption as well as opioid-related adverse effects. Epidural catheter or spinal anesthesia has become the standard of care at the University of Wisconsin-Madison for intraoperative management of TKA patients. General anesthesia is still occasionally used for patients that would strongly prefer a general anesthetic, those that are taking anticoagulation medications or with a coagulopathy, those with previous back surgery, and those with certain neurologic conditions such as multiple sclerosis or spina bifida. Comparison studies between lumbar epidural analgesia and femoral nerve catheters (FNC) for postoperative analgesia following TKA show no significant difference in pain scores, morphine consumption, or post-operative nausea and vomiting. However, epidural analgesia has been associated with higher incidence of hypotension and urinary retention. FNC's placed for postoperative pain allow patients to ambulate more effectively as there should not be much of a lower extremity motor block. Patients with a FNC for postoperative analgesia also do not require a urinary catheter which eliminates a common source of infection in postoperative patients. FNCs have also demonstrated improved rehabilitation times and decreased hospital stays which has led to an increased insertion rate of FNCs for postoperative analgesia following TKA at the University of Wisconsin. Pyarthrosis is a fairly common complication occurring at a rate of 2% following primary and 5.6% following revision TKA. Infection can be a devastating complication following implantation of joint hardware often leading to extended hospitalization/rehabilitation stays and return trips to the operating room. The average billed charges for all types of revision TKA procedures was $49,360 with average length of stay of 5.1 days. Indwelling lines are a known infection risk and indwelling lines in the femoral region are known to be associated with a high incidence of catheter colonization. At 48 hours, Cuvillon et. al. found that 57% of FNCs placed without the use of a chlorhexidine impregnated patch had positive bacterial colonization. They also described three cases of transient bacteremia secondary to FNCs in the 208 catheters that they analyzed. Chlorhexidine impregnated patches also known as "biopatches" have been shown to reduce the incidence of bacterial colonization and infection of various indwelling lines including epidurals and central venous catheters. Currently no standard of care exists that requires the use of biopatches for FNCs. The investigators propose studying the use of the biopatch to reduce the incidence of bacterial colonization of femoral nerve catheters. The investigators will study the efficacy of the biopatch at decreasing the rate of bacterial colonization of FNCs in TKA patients. The FNCs will be inserted in the standard fashion and removed at the end of therapy. Typically the FNC infusion will continue until the morning of post-operation day (POD) #1 or 2. The process for FNC insertion first involves sterile prep and drape of the femoral region. Full sterile technique will be utilized including gown, gloves, and mask. Ultrasound guidance is then commonly utilized to identify the femoral nerve. Following patient sedation and skin infiltration with local anesthetic, a tuohy needle is inserted adjacent to the femoral nerve. A catheter is then threaded through the needle in close proximity to the femoral nerve. Patients will be randomized to either no chlorhexidine impregnated patch or to a chlorhexidine impregnated patch that will be located at the catheter exit site. On the morning of POD 1 or 2, the FNC infusion will be discontinued. Typically, Twenty-four to forty-eight hours after catheter insertion, it will be removed in a sterile fashion and the skin surrounding the catheter exit site will be swabbed and the distal catheter tip will be sent for culture to determine bacterial colonization. In addition, the investigators will interview patients and review clinical data to determine signs of infection and/or catheter tip colonization rates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter Infections, Spinal Catheter (Epidural) (Subdural); Complications, Infection or Inflammation
Keywords
Arthroplasty, Infection Control

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
Arm Title
Chlorhexidine impregnated patch.
Arm Type
Experimental
Arm Description
Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
Intervention Type
Device
Intervention Name(s)
Chlorhexidine impregnated patch (Biopatch)
Other Intervention Name(s)
Biopatch
Intervention Description
Patients assigned to the intervention group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
Primary Outcome Measure Information:
Title
Catheter Tip Colonization
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.
Secondary Outcome Measure Information:
Title
Catheter Insertion Site Colonization.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients age 18-85 undergoing elective knee arthroplasty who elect to have a femoral nerve block catheter placed for postoperative analgesia. Exclusion Criteria: Allergy to local anesthetics, local or generalized infection or inflammation, current antibiotic therapy, immunocompromised patients, a history of chronic steroid use, neurological deficits, pregnancy, prisoners, refusal to participate, primary language other than English, and patients currently participating in a study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristopher M Schroeder, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17403800
Citation
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Citation
Hu S, Zhang ZY, Hua YQ, Li J, Cai ZD. A comparison of regional and general anaesthesia for total replacement of the hip or knee: a meta-analysis. J Bone Joint Surg Br. 2009 Jul;91(7):935-42. doi: 10.1302/0301-620X.91B7.21538.
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PubMed Identifier
19130163
Citation
Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anesthesia improve outcome after total knee arthroplasty? Clin Orthop Relat Res. 2009 Sep;467(9):2379-402. doi: 10.1007/s11999-008-0666-9. Epub 2009 Jan 7.
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PubMed Identifier
18211990
Citation
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PubMed Identifier
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Citation
Bozic KJ, Kurtz SM, Lau E, Ong K, Chiu V, Vail TP, Rubash HE, Berry DJ. The epidemiology of revision total knee arthroplasty in the United States. Clin Orthop Relat Res. 2010 Jan;468(1):45-51. doi: 10.1007/s11999-009-0945-0. Epub 2009 Jun 25.
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PubMed Identifier
11574381
Citation
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Results Reference
derived

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

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