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Clinical trial

Test for Preinjection Skin Preparation

ID
Name
371.1.04.19.11
Description
The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep One-Step Frepp Applicator.
Trial arms
Trial start
2011-05-01
Estimated PCD
2011-06-01
Trial end
2011-06-01
Status
Completed
Phase
Early phase I
Treatment
ChloraPrep One-Step
1.5 ml applicator patient preoperative skin preparation
70% isopropyl alcohol
Curity Alcohol Prep Pads
Other names:
Positive Control
Size
25
Primary endpoint
Antimicrobial Efficacy
30 seconds after treatment
Antimicrobial Efficacy
10 minutes after treatment
Eligibility criteria
Inclusion Criteria: * in good general health * have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders. Exclusion Criteria: - topical or systemic antimicrobial exposure within 14 days prior to the Screen Visit
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}
Updated at
2023-07-18

1 organization

2 products

1 indication

Organization
CareFusion
Product
Isopropyl alcohol
Indication
Antimicrobial Effectiveness
Product
ChloraPrep