NCT03326726CompletedPhase 2
Evaluation of the Area Covered by Medline 2% Chlorhexidine Gluconate Cloth Preoperative Skin Preparation
Medline Industries0 sites30 target enrollmentStarted: November 16, 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Primary Endpoint
- Medline 2% CHG Cloth Dosage of Coverage Area
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts 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.
Exclusion Criteria
- Not provided
Arms & Interventions
Chlorhexidine Gluconate
Experimental
2% CHG
Intervention: 2% CHG (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Post-application Drying Time(Approximately 1 minute)
Investigators
Similar Trials
Completed
Not Applicable
Eliminate Risk of Cardiac Surgical Site EventsSurgical Site InfectionsNCT01425697University of Rochester739
Completed
Phase 3
Preoperative CHG Cloth on Healthy SubjectsSurgeryNCT02291601Medline Industries879
Completed
Phase 3
Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy SubjectsSurgeryNCT02222896Medline Industries347
Completed
Phase 3
Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy VolunteersSurgeryNCT02526667Medline Industries340
Completed
Not Applicable
Study of a New Dressing for Use With Topical MedicationsPsoriasisNCT00234728Teikoku Pharma USA, Inc.120