Skin Coverage
Conditions
Brief 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 treatment area (7 x 10 of the subject's back), and the skin was allowed to air dry.
Interventions
DRUG2% CHG
Chlorhexidine Gluconate
Sponsors
Medline Industries
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medline 2% CHG Cloth Dosage of Coverage Area | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-application Drying Time | 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. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 2% CHG Cloth 2% chlorhexidine gluconate cloth | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | 2% CHG Cloth |
|---|---|
| Age, Continuous | 34 years STANDARD_DEVIATION 15 |
| Race/Ethnicity, Customized Race/Ethniticy Asian | 11 Participants |
| Race/Ethnicity, Customized Race/Ethniticy Black or African American | 7 Participants |
| Race/Ethnicity, Customized Race/Ethniticy Hispanic or Latino | 2 Participants |
| Race/Ethnicity, Customized Race/Ethniticy Other | 3 Participants |
| Race/Ethnicity, Customized Race/Ethniticy White | 7 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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
Time frame: 3 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% CHG Cloth | Medline 2% CHG Cloth Dosage of Coverage Area | 0.0081 g/cm^2 | Standard Deviation 0.0013 |
Secondary
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.
Time frame: Approximately 1 minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% CHG Cloth | Post-application Drying Time | 70 seconds | Standard Deviation 18 |