Chlorhexidine Versus Betadine in Preventing Colonization of Femoral Nerve Catheters After Total Joint Arthroplasty (TJA)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by North Shore Long Island Jewish Health System
Sponsor:
Information provided by (Responsible Party):
Joseph Marino M.D., North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00896402
First received: May 7, 2009
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

Continuous femoral nerve block (CFNB) techniques continue to be increasingly used in the management of postoperative pain after total knee arthroplasty. Although the risk of full blown infection with CFNB has been poorly defined, the rate of catheter colonization after antisepsis with povidone-iodine has been demonstrated to be high (Cuivillion et al. showed the rate of colonization to be 57% after 48 hours). Recently, several anecdotal case reports have demonstrated severe infectious complications including psoas abscess and necrotizing fasciitis associated with continuous nerve block techniques. As the use of CFNB techniques increase in popularity, infectious complications will undoubtedly become more common.

The American Society of Regional Anesthesia and Pain Medicine recommends the routine use of antiseptic solutions with an alcohol base for skin disinfection before peripheral regional techniques due to their penetration of the stratum corneum and their rapid and prolonged effect. Chlorhexidine(chloraprep) has been proven to be better than povidone iodine solution for skin preparation before epidural catheter and intravascular device insertion (Kinirons et al., Ostrander et al., Mimoz et al.,). The goal of this prospective trial therefore is to determine if an alcoholic solution of 0.5% chlorhexidine is more effective than an aqueous solution of 10% povidone-iodine in reducing catheter colonization and reducing skin flora associated with short term ( 48 hours) postoperative continuous femoral nerve catheter placement. The investigators will also compare the ability of chloraprep and betadine disinfection at the time of catheter placement to prevent bacterial contamination of the continuous femoral catheter.


Condition Intervention
Infection
Drug: Skin antisepsis with chlorhexidine
Drug: povidone-iodine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Chlorhexidine vs. Betadine in Preventing Colonization of Continuous Femoral Catheters After Total Joint Arthroplasty

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Presence or absence of bacterial colonization of the distal femoral catheter tip 48 hours after antiseptic application [ Time Frame: July 2013 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidences of bacterial colonization of skin before/after skin antisepsis and skin/catheter interface [ Time Frame: July 2013 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chlorhexidine
skin antisepsis with chlorhexidine
Drug: Skin antisepsis with chlorhexidine
Chlorhexidine swabs will be used to antiseptically clean the skin, then cultures of the skin and femoral nerve block catheters will be analyzed via standard microbiological techniques
Other Name: Chlora-prep: 2% w/v chlorhexidine and 70% v/v isopropyl alcohol
Active Comparator: Povidone-iodine
skin antisepsis with povidone-iodine
Drug: povidone-iodine
Povidone-iodine swabs will be used to antiseptically clean the skin; then cultures of the skin and femoral nerve catheters will be performed by standard microbiologic techniques
Other Name: Povidone-Iodine, USP 10% topical solution

Detailed Description:

After antisepsis four different cultures will be analyzed:

  1. The femoral nerve catheter will be removed after 48 hours and a culture of the distal tip of the femoral nerve catheter will be performed between the 2 arms.
  2. immediately before skin antisepsis, a culture of the the skin will be performed to identify baseline skin flora.
  3. immediately after antisepsis with both betadine and chlorhexidine, a culture of the skin will be performed to assess antiseptic efficacy.
  4. just prior to removal of the femoral nerve catheter, a culture of the skin/catheter interface will be performed between the 2 arms.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA 1-3,
  • Undergoing primary total knee arthroplasty.

Exclusion Criteria:

  • Hypersensitivity/allergy to antiseptics,
  • Recent opioid/alcohol abuse,
  • Presence of contraindications to regional anesthesia,
  • Coagulation disorder,
  • Diabetic/femoral neuropathy,
  • Prior surgery to inguinal area,
  • Patient refusal.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896402

Contacts
Contact: Joseph Marino, M.D. 631-300-8709 drjnange@aol.com

Locations
United States, New York
Franklin Hospital Not yet recruiting
Valley Stream, New York, United States, 11580
Contact: Joseph Marino, M.D.    631-300-8709      
Principal Investigator: Joseph Marino, M.D.         
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Joseph Marino, M.D. Franklin Hospital
  More Information

No publications provided

Responsible Party: Joseph Marino M.D., Chief of Anesthesiology, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00896402     History of Changes
Other Study ID Numbers: 1989mdmd
Study First Received: May 7, 2009
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
chloraprep
betadine
colonization
femoral catheter

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Iodine
Povidone
Povidone-Iodine
Anti-Infective Agents
Anti-Infective Agents, Local
Blood Substitutes
Dermatologic Agents
Disinfectants
Growth Substances
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Plasma Substitutes
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on October 23, 2014