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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kristopher Schroeder, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01411891
First received: May 17, 2011
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Catheter Infections
Spinal Catheter (Epidural) (Subdural); Complications, Infection or Inflammation
Device: Chlorhexidine impregnated patch (Biopatch)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective Randomized Control Trial of Post-Operative Colonization Rates of Femoral Nerve Catheters With the Use of Chlorhexidine-Impregnated Patch

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Catheter Tip Colonization [ Time Frame: 24-48 hours after placement of femoral nerve catheter. ] [ Designated as safety issue: Yes ]
    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.

  • Femoral Nerve Catheter Bacterial Colonization [ Time Frame: Colonization measured following catheter removal (approximately 48 hours after placement). ] [ Designated as safety issue: No ]
    Describes rate of femoral nerve catheter bacterial colonization.


Secondary Outcome Measures:
  • Catheter Insertion Site Colonization. [ Time Frame: 24-48 hours. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 100
Study Start Date: August 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
Experimental: Chlorhexidine impregnated patch.
Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
Device: Chlorhexidine impregnated patch (Biopatch)
Patients assigned to the intervention group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
Other Name: Biopatch

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01411891

Locations
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Kristopher M Schroeder, MD University of Wisconsin, Madison
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kristopher Schroeder, Assistant Professor, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01411891     History of Changes
Other Study ID Numbers: 2010-0444
Study First Received: May 17, 2011
Results First Received: April 20, 2012
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Arthroplasty
Infection Control

Additional relevant MeSH terms:
Communicable Diseases
Infection
Inflammation
Pathologic Processes
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014