NCT02095535

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

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2014

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

August 7, 2017

Completed
Last Updated

August 7, 2017

Status Verified

April 1, 2017

Enrollment Period

2 months

First QC Date

March 19, 2014

Results QC Date

April 27, 2017

Last Update Submit

April 27, 2017

Conditions

Keywords

obstetric patientschloraprepchlorhexidinedrying time

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

Drug: Chlorhexidine gluconate

Interventions

antiseptic

Also known as: Chloraprep
Study group

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Interventions

chlorhexidine gluconate

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

  • Vit Gunka, MD FRCPC

    University of British Columbia

    PRINCIPAL INVESTIGATOR

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

Locations