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

This study has been completed.
Sponsor:
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00223002
First received: September 19, 2005
Last updated: February 12, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention
Asepsis
Analgesia, Epidural
Anesthesia, Epidural
Drug: Chlorhexidine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Chlorhexidine Versus Povidone-Iodine for Prevention of Epidural Needle Contamination in the Parturient

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • culture-positive rate of epidural needles processed by microbiology lab [ Time Frame: immediate ]

Estimated Enrollment: 400
Study Start Date: November 2004
Study Completion Date: January 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PI
Drug: Chlorhexidine
sample collected at time of procedure and then analysed for bacterial contamination
Experimental: 2
Chlorohex
Drug: Chlorhexidine
sample collected at time of procedure and then analysed for bacterial contamination

Detailed 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223002

Locations
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
Investigators
Principal Investigator: Susan A Shaw, MD University of Saskatchewan College of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00223002     History of Changes
Other Study ID Numbers: BMC# 03-1315
Study First Received: September 19, 2005
Last Updated: February 12, 2009
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Povidone-Iodine
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014