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CompletedNCT02095535ChlorhexidineUpdated Aug 7, 2017Results posted

Chlorhexidine Drying Time

An observational study in Drying Time, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to female participants aged 19 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-07.

Sponsored by University of British Columbia · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
20
Ages
19 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Drying Time

Keywords

  • obstetric patients
  • chloraprep
  • chlorhexidine
  • drying time
03

In context

Lead sponsor

University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Elective cesarean patients at BC Women's Hospital

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

Exclusion Criteria:

  • Allergy to certain antiseptic solutions
  • Not suitable for a spinal/epidural anesthetic
  • Have a significant amount of hair on lower back
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Study group

    All study participants

    Drug: Chlorhexidine gluconate

Interventions

  • DrugChlorhexidine gluconate

    antiseptic

    Also known as: Chloraprep

06

What researchers measure

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.

    Time frame: At Chloraprep application

07

Results

Posted Aug 7, 2017
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

Participant flow

Recruitment
Participant flow — Recruitment
MilestoneStudy Group
Started20
Completed18
Not completed2
Withdrew: Protocol violation2
Analysis
Participant flow — Analysis
MilestoneStudy Group
Started18
Completed18
Not completed0

Outcome measures

PrimaryLength of Drying Time

Length of drying time from when Chloraprep solution is applied to skin to when skin is deemed dry.

Time frame:
At Chloraprep application
Reported as:
Mean · seconds
Length of Drying Time
secondsStudy Group
Length of Drying Time123 ± 32

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Study Group———

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Study Group
<=18 years0
Between 18 and 65 years18
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Study Group
Female18
Male0
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Study Group
Region of Enrollment
Region of Enrollment(participants)Study Group
Canada18
08

Study locations

1 site
  • BC Women's Hospital
    Vancouver, British Columbia V6H 3N1, Canada
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02095535
Lead sponsor
University of British Columbia
Responsible party
Vit Gunka (Principle Investigator, University of British Columbia) — Principal investigator
First posted
Mar 24, 2014
Start date
Apr 2014
Primary completion
Jun 2014
Completion
Jun 2014
Results posted
Aug 7, 2017
Last update
Aug 7, 2017

Study contacts

Vit Gunka, MD FRCPC
principal investigator · University of British Columbia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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