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Trial Outcomes & Findings for Evaluation 2% Chlorhexidine Gluconate (NCT NCT03326726)

NCT ID: NCT03326726

Last Updated: 2023-09-28

Results Overview

To measure the dosage of the coverage area of a single investigational test article, Medline 2% CHG cloth calculated in grams per square centimeter

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

3 minutes

Results posted on

2023-09-28

Participant Flow

Healthy males 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 histroy of sensitivity to CHG and able to lie prone for up to 30 minutes.

Participant milestones

Participant milestones
Measure
2% CHG Cloth
2% chlorhexidine gluconate cloth
Overall Study
STARTED
30
Overall Study
COMPLETED
30
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation 2% Chlorhexidine Gluconate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
2% CHG Cloth
n=30 Participants
2% chlorhexidine gluconate cloth
Age, Continuous
34 years
STANDARD_DEVIATION 15 • n=99 Participants
Sex: Female, Male
Female
0 Participants
n=99 Participants
Sex: Female, Male
Male
30 Participants
n=99 Participants
Race/Ethnicity, Customized
Race/Ethniticy · White
7 Participants
n=99 Participants
Race/Ethnicity, Customized
Race/Ethniticy · Black or African American
7 Participants
n=99 Participants
Race/Ethnicity, Customized
Race/Ethniticy · Hispanic or Latino
2 Participants
n=99 Participants
Race/Ethnicity, Customized
Race/Ethniticy · Asian
11 Participants
n=99 Participants
Race/Ethnicity, Customized
Race/Ethniticy · Other
3 Participants
n=99 Participants
Region of Enrollment
United States
30 participants
n=99 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
2% CHG Cloth
n=30 Participants
2% chlorhexidine gluconate cloth
Medline 2% CHG Cloth Dosage of Coverage Area
0.0081 g/cm^2
Standard Deviation 0.0013

SECONDARY outcome

Timeframe: Approximately 1 minute

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.

Outcome measures

Outcome measures
Measure
2% CHG Cloth
n=30 Participants
2% chlorhexidine gluconate cloth
Post-application Drying Time
70 seconds
Standard Deviation 18

Adverse Events

2% CHG Cloth

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sr. Regulatory Affairs Specialist

Medline Industries

Phone: 847-643-3515

Results disclosure agreements

  • Principal investigator is a sponsor employee Data remains confidential
  • Publication restrictions are in place

Restriction type: OTHER