Post-Operative Colonization Rates of Femoral Nerve Catheters Treated With Chlorhexidine-Impregnated Patch
Condition: Catheter Infections; Spinal Catheter (Epidural) (Subdural); Complications, Infection or Inflammation
MeSH terms: Infections; Communicable Diseases; Inflammation
Study type: Interventional
Phase: Phase 4

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.
    


Intervention name(s): Chlorhexidine impregnated patch (Biopatch)
Intervention type(s): Device
Intervention description(s): Patients assigned to the intervention group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
Other intervention name(s): Biopatch
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Arthroplasty; Infection Control