Chlorhexidine Versus Betadine in Preventing Colonization of Femoral Nerve Catheters After Total Joint Arthroplasty (TJA)
Information source: North Shore Long Island Jewish Health System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection
Intervention: Skin antisepsis with chlorhexidine (Drug); povidone-iodine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: North Shore Long Island Jewish Health System Official(s) and/or principal investigator(s):
Joseph Marino, M.D., Principal Investigator, Affiliation: Franklin Hospital
Overall contact:
Joseph Marino, M.D., Phone: 631-300-8709, Email: drjnange@aol.com
Summary
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.
Clinical Details
Official title: Chlorhexidine vs. Betadine in Preventing Colonization of Continuous Femoral Catheters After Total Joint Arthroplasty
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Presence or absence of bacterial colonization of the distal femoral catheter tip 48 hours after antiseptic application
Secondary outcome: Incidences of bacterial colonization of skin before/after skin antisepsis and skin/catheter interface
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
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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.
Locations and Contacts
Joseph Marino, M.D., Phone: 631-300-8709, Email: drjnange@aol.com
Syosset Hospital, Syosset, New York 11791, United States; Recruiting
Joseph Marino, MD
Franklin Hospital, Valley Stream, New York 11580, United States; Recruiting
Joseph Marino, M.D., Phone: 631-300-8709
Joseph Marino, M.D., Principal Investigator
Additional Information
Starting date: July 2014
Last updated: December 1, 2014
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