Skin CoveragePhase 2NCT03326726

Evaluation 2% Chlorhexidine Gluconate

A Phase 2 study testing 2% CHG in people with Skin Coverage, run by Medline Industries.

Completed

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

Trial summary

Medline 2% CHG cloth (Active) - A single cloth from the pack was used per treatment area. The investigational test article was applied topically by vigorously scrubbing the skin in a back and forth motion for three minutes (and halfway through the 3-minute application time, the cloth was turned over) over the… Read more about this study

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Skin Coverage
What is being tested?: 2% CHG
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: 16 Nov 2016to 18 Nov 2016
Phase: Phase 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
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy males of at least 18 years of age having skin within 6 inches of the test regions that were free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders, with no history of sensitivity to CHG and were able to lie prone for up to 30 minutes.

Who cannot join

None listed.

About this study

Official title: Evaluation of the Area Covered by Medline 2% Chlorhexidine Gluconate Cloth Preoperative Skin Preparation

Conditions: Skin Coverage
Being tested: 2% CHG

What participants receive

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

2% CHGDrug
Also called Medline 2% CHG cloth
Chlorhexidine Gluconate

Study groups in NCT03326726
Study group	Role	What they receive
Chlorhexidine Gluconate	Experimental	2% CHG Receives: Drug: 2% CHG

What is being measured

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

Medline 2% CHG Cloth Dosage of Coverage Area
To measure the dosage of the coverage area of a single investigational test article, Medline 2% CHG cloth calculated in grams per square centimeter
Measured: 3 minutes

Secondary outcomes (1)

Post-application Drying Time
To assess post-application drying time after a single dose topical application of Medline 2% CHG cloth. Drying time is defined as when the entire treatment area appears visibly dry.
Measured: Approximately 1 minute

Timeline

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

16 Nov 201618 Nov 2016

First posted31 Oct 2017
Study start16 Nov 2016
Primary completion18 Nov 2016
Study completion18 Nov 2016

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 Skin CoverageStudies 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 2
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03326726
Sponsor's protocol ID: R16-034
Status last verified: Sep 2023
First submitted: 23 Oct 2017
Last updated: 28 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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 Skin Coverage trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Area Covered by Medline 2% Chlorhexidine Gluconate Cloth Preoperative Skin Preparation
ClinicalTrials.gov ID: NCT03326726
Acronym / sponsor ID: R16-034
Conditions: Skin Coverage
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Medline IndustriesIndustry (pharma, biotech, devices)
Study start: 16 Nov 2016 (actual)
Primary completion: 18 Nov 2016 (actual)
Study completion: 18 Nov 2016 (actual)
First posted: 31 Oct 2017 (actual)
Results: Posted 28 Sep 2023

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Chlorhexidine Gluconate	Experimental	Drug: 2% CHG2% CHG

Who may qualify

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

Key inclusion criteria (1 listed)

Healthy males of at least 18 years of age having skin within 6 inches of the test regions that were free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders, with no history of sensitivity to CHG and were able to lie prone for up to 30 minutes.

Key exclusion criteria (0 listed)

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
2% CHGAlso: Medline 2% CHG clothChlorhexidine Gluconate	Drug	Chlorhexidine Gluconate

Primary outcome

Medline 2% CHG Cloth Dosage of Coverage Area
Time frame: 3 minutes
To measure the dosage of the coverage area of a single investigational test article, Medline 2% CHG cloth calculated in grams per square centimeter

1 secondary outcome

Post-application Drying Time
Time frame: Approximately 1 minute

Results and safety

Results posted to the registry on 28 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2% CHG Cloth	30	30

Primary outcome: Medline 2% CHG Cloth Dosage of Coverage Area

Time frame: 3 minutes. Mean (Standard Deviation). Unit: g/cm^2

Measure	2% CHG Cloth n = 30
Value	0.0081 (0.0013)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2% CHG Cloth	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Skin Coverage

Not yet recruitingObservational study
An Overview of Vaccination Coverage Among Patients Receiving Treatment for Breast Cancer at the ICO: Identifying Factors Associated With Vaccination Uptake and Improved Prevention
Breast Cancer
RecruitingObservational study
Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study
Clinical Stage II Cutaneous Merkel Cell Carcinoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
Not yet recruiting
Tape Application Protocol for Enhanced Scars
Scar Improvement, Cosmetic Outcome
Active, not recruitingPhase 3
SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II)
Diabetic Foot

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.

Hamid Bashir principal investigator

Microbac Laboratories, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 2% CHG in people with Skin Coverage, 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 1 inclusion and 0 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 28 Sep 2023. 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 phase mean?

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 28 Sep 2023). 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?

Medline 2% CHG Cloth Dosage of Coverage Area (time frame: 3 minutes). 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 NCT03326726.

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 28 Sep 2023.