Chlorhexidine Versus Povidone-Iodine for Prevention of Epidural Needle Contamination in the Parturient

Analgesia, Epidural Clinical Trial

Official title:

Chlorhexidine Versus Povidone-Iodine for Prevention of Epidural Needle Contamination in the Parturient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223002
• Other study ID #: BMC# 03-1315
• Status: Completed
• Phase: N/A
• First received: September 19, 2005
• Last updated: February 12, 2009
• Start date: November 2004
• Est. completion date: January 2008

Study information

• Verified date: February 2009
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Infection after epidural catheter placement is fortunately rare. When it does happen, the affected person can become seriously ill.

This study examines which skin disinfectant, chlorhexidine or povidone-iodine, decreases the number of bacteria that can be grown from the skin washed with each disinfectant prior to placing an epidural catheter for pain control in labour.

Description:

The use of chlorhexidine for skin asepsis for the placement of intravascular catheters is known to decrease the incidence of central line colonization and blood stream infection when compared to the use of povidone-iodine. While the development of an infectious complication following spinal or epidural analgesia, such as epidural abscess or meningitis, is fortunately rare, when it does happen, there can be devastating consequences for the affected individual. The low frequency of infection makes a trial with an endpoint of clinical infection not feasible, however a reduction in skin and needle contamination following attempts at asepsis should reduce the risk of infectious complication. Ongoing work by the authors is examining the skin culture rates following randomized standardized skin disinfection. The purpose of this randomized trial is to compare needle culture rates to further assess effectiveness of skin disinfection following a standardized skin preparation with either povidone-iodine or chlorhexidine in pregnant women requesting lumbar epidural pain relief in labour.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 2008
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Parturients requesting lumbar labour epidural analgesia while investigator is assigned to the Obstetrical Anesthesia Service

Exclusion Criteria:

• Known allergy to either skin disinfectant

• Requirement to receive antibiotics prior to placement of lumbar epidural catheter

• Immunosuppression of the participant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Analgesia, Epidural
• Anesthesia, Epidural
• Asepsis

Intervention

Drug:
• Chlorhexidine
sample collected at time of procedure and then analysed for bacterial contamination

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	culture-positive rate of epidural needles processed by microbiology lab		immediate