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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02095535
Other study ID # H14-00623
Secondary ID
Status Completed
Phase N/A
First received March 19, 2014
Last updated September 26, 2014
Start date April 2014
Est. completion date June 2014

Study information

Verified date September 2014
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

Before a patient gets a spinal/epidural, their lower back is cleaned with an antiseptic solution diluted in alcohol called ChloraPrep. ChloraPrep must completely dry before starting the anesthetic procedure. It is not known how much time is needed for the solution to completely dry. The investigators aim to determine this.

As the ChloraPrep dries, the alcohol is converted into vapour. The investigators will be using a PPBRae 3000 device to detect small amounts of vapours in the air. As the ChloraPrep dries it gives off less and less vapour. The investigators will use this diminishing vapour concentration to determine when drying is complete.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years to 40 Years
Eligibility Inclusion Criteria:

- Pregnant

- At full term

- Due to have a cesarean section under spinal or epidural anesthesia

- 19 to 40 years of age

Exclusion Criteria:

- Allergy to certain antiseptic solutions

- Not suitable for a spinal/epidural anesthetic

- Have a significant amount of hair on lower back

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Drug:
Chlorhexidine gluconate
antiseptic

Locations

Country Name City State
Canada BC Women's Hospital Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Length of drying time Length of drying time from when Chloraprep solution is applied to skin to when skin is deemed dry. At Chloraprep application Yes