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
216 participants
INTERVENTIONAL
2011-03-31
2011-04-30
Brief Summary
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Detailed Description
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Data for irritation, adhesion and pain upon removal will be collected from the individual patch sites.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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IV Clear™
IV Clear™
Polyurethane film with a silicone adhesive dressing containing chlorhexidine and silver
Tegaderm CHG™
Tegaderm CHG™
Polyurethane film with a polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate
Control Vehicle Dressing
Silicone Vehicle Control Dressing
Polyurethane film with silicone adhesive dressing, without antimicrobials
Interventions
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IV Clear™
Polyurethane film with a silicone adhesive dressing containing chlorhexidine and silver
Tegaderm CHG™
Polyurethane film with a polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate
Silicone Vehicle Control Dressing
Polyurethane film with silicone adhesive dressing, without antimicrobials
Eligibility Criteria
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Inclusion Criteria
* In good health, as determined by medical history and concomitant medication
* Able to comprehend and sign informed consent
* Unable to bear children or willing to use adequate birth control
* Willing and able to follow study directions, to participate in the study and to return for all specific visit
Exclusion Criteria
* Diabetes (any type)
* Mastectomy involving removal of lymph nodes
* Clinically significant skin disease, including but not limited to psoriasis, eczema, atopic dermatitis, and active cancer
* Asthma or other severe respiratory disease requiring medication
* Self-reported immunological disorders including (but not limited to) HIV positive, AIDS, rheumatoid arthritis, and systematic lupus erythematosus
* Treatment of any type of cancer within the last two years or history of skin cancer in the test area
* Use of any of the following: topically applied products (e.g. medicals, lotions, creams, etc.) at the application site within 3 days of first application of test articles, immunosuppressive drugs within 30 days of first application of test articles, systemic or topical corticosteroids within 30 days of first application of test articles, and systemic or topically applied anti-inflammatory and antihistamine medications within 3 days of first application of test articles
* Participation in any patch test for irritation or sensitization within the last four weeks
* Participation in any investigational drug study within the last four weeks
* Damaged skin in or around the test sites which includes: sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfiguration
* Known sensitization to adhesives, bandages, or materials used in test articles
* Medical condition which, in investigator's judgment, makes the subject ineligible or places the subject at undue risk
18 Years
100 Years
ALL
Yes
Sponsors
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Covalon Technologies Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Micah Humphrey, B.S.
Role: PRINCIPAL_INVESTIGATOR
Hill Top Research
Locations
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Hill Top Research
St. Petersburg, Florida, United States
Countries
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Other Identifiers
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TP-015
Identifier Type: -
Identifier Source: org_study_id
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