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

NCT00896402 | Withdrawn

• 1 other identifier: 1989mdmd
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Infection

Keywords

chloraprep; betadine; colonization; femoral catheter

Outcome Measures

Primary Outcomes (1)

• Presence or absence of bacterial colonization of the distal femoral catheter tip 48 hours after antiseptic application

  July 2013

Secondary Outcomes (1)

• Incidences of bacterial colonization of skin before/after skin antisepsis and skin/catheter interface

  July 2013

Study Arms (2)

Chlorhexidine

ACTIVE COMPARATOR

skin antisepsis with chlorhexidine

Drug: Skin antisepsis with chlorhexidine

Povidone-iodine

ACTIVE COMPARATOR

skin antisepsis with povidone-iodine

Drug: povidone-iodine

Interventions

Skin antisepsis with chlorhexidine DRUG

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

Also known as: Chlora-prep: 2% w/v chlorhexidine and 70% v/v isopropyl alcohol

Chlorhexidine

povidone-iodine DRUG

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

Also known as: Povidone-Iodine, USP 10% topical solution

Povidone-iodine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (2)

Syosset Hospital

Syosset, New York, 11791, United States

Location

Franklin Hospital

Valley Stream, New York, 11580, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Chlorhexidine; Ethanol; Povidone-Iodine; Solutions

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Alcohols; Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Pharmaceutical Preparations

Study Officials

• Joseph Marino, M.D.

  Franklin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Anesthesiology

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: May 11, 2009
• Study Start: July 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 27, 2015

Record last verified: 2015-08

Locations

US (2)