Chlorhexidine Drying Time
Chlorhexidine
The Minimum ChloraPrep Drying Time Before Neuraxial Anesthesia in Elective Cesarean Delivery Patients - Prospective Observational Study
1 other identifier
observational
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2014
CompletedFirst Posted
Study publicly available on registry
March 24, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
August 7, 2017
CompletedAugust 7, 2017
April 1, 2017
2 months
March 19, 2014
April 27, 2017
April 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Study group
All study participants
Interventions
Eligibility Criteria
Elective cesarean patients at BC Women's Hospital
You may qualify if:
- Pregnant
- At full term
- Due to have a cesarean section under spinal or epidural anesthesia
- to 40 years of age
You may not qualify if:
- Allergy to certain antiseptic solutions
- Not suitable for a spinal/epidural anesthetic
- Have a significant amount of hair on lower back
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BC Women's Hospital
Vancouver, British Columbia, V6H 3N1, Canada
MeSH Terms
Interventions
Limitations and Caveats
* Small sample size * Severe methodological assumptions (i.e. measuring of ChloraPrep drying time, lack of gold standard to assess wetness/dryness * Patient's variables could influence wetness * No enrollment of high BMI patients with skin folds
Results Point of Contact
- Title
- Tashya De Silva
- Organization
- UBC Department of Anesthesia - BC Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Vit Gunka, MD FRCPC
University of British Columbia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
March 19, 2014
First Posted
March 24, 2014
Study Start
April 1, 2014
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
August 7, 2017
Results First Posted
August 7, 2017
Record last verified: 2017-04