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

Sponsor

Northwell Health (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00896402

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infection	Drug: Skin antisepsis with chlorhexidine Drug: povidone-iodine	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Chlorhexidine vs. Betadine in Preventing Colonization of Continuous Femoral Catheters After Total Joint Arthroplasty

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Povidone-Iodine, USP 10% topical solution

Arm

Intervention/Treatment

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 Names:

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 Names:

Povidone-Iodine, USP 10% topical solution