Drying TimeChlorhexidineNCT02095535
Chlorhexidine Drying Time
An observational study of Drying Time, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Drying Time
- What is being tested?
- Chlorhexidine gluconate
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Jun 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Elective cesarean patients at BC Women's Hospital
Who may be able to join
- Pregnant
- At full term
- Due to have a cesarean section under spinal or epidural anesthesia
- 19 to 40 years of age
Who cannot join
- Allergy to certain antiseptic solutions
- Not suitable for a spinal/epidural anesthetic
- Have a significant amount of hair on lower back
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Minimum ChloraPrep Drying Time Before Neuraxial Anesthesia in Elective Cesarean Delivery Patients - Prospective Observational Study
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.
- Conditions
- Drying Time
- Being tested
- Chlorhexidine gluconate
- Keywords
- obstetric patients, chloraprep, chlorhexidine, drying time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconateDrug
Also called Chloraprep
antiseptic
| Study group | Role | What they receive |
|---|---|---|
| Study group | All study participants Receives: Drug: Chlorhexidine gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Drying Time
Length of drying time from when Chloraprep solution is applied to skin to when skin is deemed dry.
Measured: At Chloraprep application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Drying TimeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vit Gunka, University of British Columbia
- Investigators
- Vit Gunka, MD FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095535
- Sponsor's protocol ID
- H14-00623
- Acronym
- Chlorhexidine
- Status last verified
- Apr 2017
- First submitted
- 19 Mar 2014
- Last updated
- 7 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Minimum ChloraPrep Drying Time Before Neuraxial Anesthesia in Elective Cesarean Delivery Patients - Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02095535
- Acronym / sponsor ID
- Chlorhexidine / H14-00623
- Conditions
- Drying Time
- Keywords
- obstetric patients, chloraprep, chlorhexidine, drying time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Posted 7 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Drug: Chlorhexidine gluconateAll study participants |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Elective cesarean patients at BC Women's Hospital
Key inclusion criteria (4 listed)
- Pregnant
- At full term
- Due to have a cesarean section under spinal or epidural anesthesia
- 19 to 40 years of age
Key exclusion criteria (3 listed)
- Allergy to certain antiseptic solutions
- Not suitable for a spinal/epidural anesthetic
- Have a significant amount of hair on lower back
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine gluconateAlso: Chloraprepantiseptic | Drug | Study group |
Primary outcome
Length of Drying Time
Time frame: At Chloraprep application
Length of drying time from when Chloraprep solution is applied to skin to when skin is deemed dry.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vit Gunka, MD FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drying Time, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Drying Time (time frame: At Chloraprep application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2017.