Clinical trial

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

Name
R16-034
Description
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.
Trial arms
Trial start
2016-11-16
Estimated PCD
2016-11-18
Trial end
2016-11-18
Status
Completed
Phase
Early phase I
Treatment
2% CHG
Chlorhexidine Gluconate
Arms:
Chlorhexidine Gluconate
Other names:
Medline 2% CHG cloth
Size
30
Primary endpoint
Medline 2% CHG Cloth Dosage of Coverage Area
3 minutes
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2023-09-28

1 organization

1 product

1 indication

Organization
Medline Industries
Product
2% CHG
Indication
Skin Coverage