NCT00223002

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 16, 2009

Status Verified

February 1, 2009

Enrollment Period

2.2 years

First QC Date

September 19, 2005

Last Update Submit

February 12, 2009

Conditions

AsepsisAnalgesia, EpiduralAnesthesia, Epidural

Outcome Measures

Primary Outcomes (1)

  • culture-positive rate of epidural needles processed by microbiology lab

    immediate

Study Arms (2)

1

EXPERIMENTAL

PI

Drug: Chlorhexidine

2

EXPERIMENTAL

Chlorohex

Drug: Chlorhexidine

Interventions

ChlorhexidineDRUG

sample collected at time of procedure and then analysed for bacterial contamination

12

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Known allergy to either skin disinfectant
  • Requirement to receive antibiotics prior to placement of lumbar epidural catheter
  • Immunosuppression of the participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Agnosia

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Susan A Shaw, MD

    University of Saskatchewan College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

November 1, 2004

Primary Completion

January 1, 2007

Study Completion

January 1, 2008

Last Updated

February 16, 2009

Record last verified: 2009-02

Locations

CA(1)