HealthyPhase 1/2NCT02530541

Antimicrobial Efficacy of 2% CHG (Chlorhexidine Gluconate)

A Phase 1/2 study testing CHG in people with Healthy, run by Medline Industries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Pilot study to evaluate and compare activity of preoperative preparation with comparator Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: CHG
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: No sites listed yet
Study dates: Apr 2014to May 2015
Phase: Phase 1/2
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy
No dermatological conditions

Who cannot join

Sensitivity to CHG
Sensitivity to natural latex rubber or adhesive skin products

About this study

Official title: Pilot Trial Assessment of the Antimicrobial Efficacy of Medline 2% CHG Cloth Preoperative Skin Preparation

Pilot study to evaluate and compare activity of preoperative preparation with comparator

Read the detailed description

Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using TFM criteria.

Conditions: Healthy
Being tested: CHG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CHGDrug
Also called Chlorhexidine Gluconate
Varied application times

Study groups in NCT02530541
Study group	Role	What they receive
CHG 1 min	Experimental	1 min application time Receives: Drug: CHG
CHG 2 min	Experimental	2 min application time Receives: Drug: CHG
Comparator CHG	Active comparator	Marketed CHG Receives: Drug: CHG

What is being measured

The primary outcome is the main question the study is designed to answer.

Log Reduction of Bacterial Flora on the Abdomen and Groin
Evaluate the Log Reduction of normal flora at various timepoints.
Measured: 10 min, 6 hr and 8 hr

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014May 2015

First posted21 Aug 2015 (estimated)
Study startApr 2014
Primary completionJul 2014
Study completionMay 2015

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 HealthyStudies of the same condition, open and under way.
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: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02530541
Sponsor's protocol ID: R14-015
Status last verified: Sep 2020
First submitted: 16 Aug 2015
Last updated: 30 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Data to be shared with FDA

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Trial Assessment of the Antimicrobial Efficacy of Medline 2% CHG Cloth Preoperative Skin Preparation
ClinicalTrials.gov ID: NCT02530541
Acronym / sponsor ID: R14-015
Conditions: Healthy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Medline IndustriesIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Jul 2014 (actual)
Study completion: May 2015 (actual)
First posted: 21 Aug 2015 (estimated)
Results: Posted 30 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Pilot study to evaluate and compare activity of preoperative preparation with comparator

Detailed description

Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using TFM criteria.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
CHG 1 min	Experimental	Drug: CHG1 min application time
CHG 2 min	Experimental	Drug: CHG2 min application time
Comparator CHG	Active comparator	Drug: CHGMarketed CHG

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Healthy
No dermatological conditions

Key exclusion criteria (2 listed)

Sensitivity to CHG
Sensitivity to natural latex rubber or adhesive skin products

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
CHGAlso: Chlorhexidine GluconateVaried application times	Drug	CHG 1 min, CHG 2 min, Comparator CHG

Primary outcome

Log Reduction of Bacterial Flora on the Abdomen and Groin
Time frame: 10 min, 6 hr and 8 hr
Evaluate the Log Reduction of normal flora at various timepoints.

Results and safety

Results posted to the registry on 30 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CHG 1 Min Abdomen	21	14
CHG 2 Min Abdomen	23	15
Comparator CHG Abdomen	22	14
CHG 1 Min Groin	21	15
CHG 2 Min Groin	20	15
Comparator CHG Groin	19	14

Primary outcome: Log Reduction of Bacterial Flora on the Abdomen and Groin

Time frame: 10 min, 6 hr and 8 hr. Mean (Standard Deviation). Unit: Log10 Reductions

Measure	CHG 1 Min Abdomen n = 21	CHG 2 Min Abdomen n = 23	Comparator CHG Abdomen n = 22	CHG 1 Min Groin n = 21	CHG 2 Min Groin n = 20	Comparator CHG Groin n = 19
10 min	1.9 (1.6)	2.0 (1.5)	1.3 (1.8)	1.9 (0.6)	2.4 (1.1)	2.1 (1.1)
6 hour	2.6 (1.3)	2.5 (1.4)	1.7 (1.6)	2.3 (0.8)	2.8 (1.2)	1.9 (0.8)
8 hour	2.6 (1.0)	2.2 (1.6)	1.4 (1.2)	2.5 (0.9)	2.7 (0.8)	2.2 (1.1)

Population analysed: Determine 70% responder rates

Adverse events

Time frame: Adverse events were monitored from baseline out to 8 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CHG 1 Min, CHG 2 Min, Comparator CHG	0 of 33 (0%)	0 of 33 (0%)	Not reported

Limitations and caveats (from the sponsor): Small sample size.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Data to be shared with FDA

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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.

Esther Campbell principal investigator

Bioscience Labs

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CHG in people with Healthy, run by Medline Industries.

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 2 inclusion and 2 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 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2021). 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?

Log Reduction of Bacterial Flora on the Abdomen and Groin (time frame: 10 min, 6 hr and 8 hr). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02530541.

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 30 Apr 2021.