Chlorhexidine Versus Betadine in Preventing Colonization of Femoral Nerve Catheters After Total Joint Arthroplasty (TJA)
Recruitment status was Not yet recruiting
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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 |
- Presence or absence of bacterial colonization of the distal femoral catheter tip 48 hours after antiseptic application [ Time Frame: April 2010 ] [ Designated as safety issue: No ]
- Incidences of bacterial colonization of skin before/after skin antisepsis and skin/catheter interface [ Time Frame: April 2010 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2011 (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:
- 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.
- immediately before skin antisepsis, a culture of the the skin will be performed to identify baseline skin flora.
- immediately after antisepsis with both betadine and chlorhexidine, a culture of the skin will be performed to assess antiseptic efficacy.
- 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 |
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| Contact: Joseph Marino, M.D. | 631-300-8709 | drjnange@aol.com |
| United States, New York | |
| Huntington Hospital | Not yet recruiting |
| Huntington, New York, United States, 11743 | |
| Contact: Joseph Marino, M.D. 631-300-8709 | |
| Principal Investigator: Joseph Marino, M.D. | |
| Principal Investigator: | Joseph Marino, M.D. | Huntington Hospital |
More Information
No publications provided
| Responsible Party: | Joseph Marino M.D., Huntington Hospital |
| ClinicalTrials.gov Identifier: | NCT00896402 History of Changes |
| Other Study ID Numbers: | 1989mdmd |
| Study First Received: | May 7, 2009 |
| Last Updated: | July 9, 2010 |
| 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:
|
Povidone Chlorhexidine Chlorhexidine gluconate Iodine Cadexomer iodine Povidone-Iodine Plasma Substitutes Blood Substitutes Hematologic Agents Therapeutic Uses |
Pharmacologic Actions Anti-Infective Agents, Local Anti-Infective Agents Disinfectants Dermatologic Agents Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013