Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2010-04-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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CHG Catheter Dressing Patch
CHG Catheter Dressing Patch
2% CHG dressing applied to 7 sites
Biopatch
Biopatch Protective Disk with CHG
Biopatch
Biopatch applied to 7 sites
Tegaderm CHG
Tegaderm CHG IV Securement Dressing
Tegaderm CHG
Tegaderm CHG IV Securement Dressing applied to 7 sites
Interventions
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CHG Catheter Dressing Patch
2% CHG dressing applied to 7 sites
Biopatch
Biopatch applied to 7 sites
Tegaderm CHG
Tegaderm CHG IV Securement Dressing applied to 7 sites
Eligibility Criteria
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Inclusion Criteria
* Willing to shower using the same soap/cleansers from the Screening Visit through the end of the study
* Use study-approved contraceptive methods
Exclusion Criteria
* Clinically significant illness within 28 days prior to dosing.
* History of allergic responses to chlorhexidine, chlorhexidine-containing products, glycerol, adhesives, latex
* History of clinically significant skin disorders
* History of Type I diabetes mellitus, insulin-dependent diabetes mellitus(IDDM)
* History of significant dermatologic cancers (melanoma, squamous)
* Known history of immunologic disorders
* Use immunosuppressive or other proscribed medications
* Use of skin products at the application site
* Significant history of allergies to soaps, lotions, emollients, ointments, creams
* History of drug or alcohol addiction within the past year
* Pregnant, lactating, breast-feeding, or intends to become pregnant during the course of the study
18 Years
ALL
Yes
Sponsors
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C. R. Bard
INDUSTRY
Responsible Party
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Principal Investigators
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Ramon Vargas, MD
Role: PRINCIPAL_INVESTIGATOR
Cetero Research, San Antonio
Locations
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Cetero Research
Saint Charles, Missouri, United States
Countries
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Other Identifiers
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S10-0088
Identifier Type: -
Identifier Source: org_study_id
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