Chlorhexidine Versus Povidone-Iodine for Prevention of Epidural Needle Contamination in the Parturient
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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 |
- 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 |
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| Canada, Saskatchewan | |
| Royal University Hospital | |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
| 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:
|
Povidone Chlorhexidine Chlorhexidine gluconate Povidone-Iodine Plasma Substitutes Blood Substitutes Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Anti-Infective Agents, Local Anti-Infective Agents Disinfectants Dermatologic Agents |
ClinicalTrials.gov processed this record on May 22, 2013