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The purpose of this study is to assess the surface cutaneous antimicrobial activity of IV Clear™ Dressing, Tegaderm CHG™ Dressing and a Silicone Vehicle Control Dressing.
A single center, within-subject randomized study design in healthy adult subjects with a history of high bacteria counts on their upper back, meeting the inclusion criteria.
Antimicrobial efficacy will be measured by determining the mean number of Colony Forming Units (CFUs) per square centimetre (cm²) of skin prior to treatment (baseline measurement), following preparation with 70% isopropyl alcohol, and following post treatment samples.
The goal of this study is to demonstrate that IV Clear™ is as effective as or better than Tegaderm™ CHG dressing in preventing regrowth of cutaneous microbial flora on test subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Clear™ | Experimental |
| |
| Tegaderm CHG™ | Active Comparator |
| |
| Vehicle Control Dressing | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Clear™ Dressing | Device | Polyurethane film, silicone adhesive dressing with chlorhexidine and silver |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in skin microbial colonization over 7-day period of antimicrobial dressing application | Mean number of Colony Forming Units (CFUs) per square centimetre (cm²) of skin prior to treatment (baseline), following prepping with 70% isopropyl alcohol and following post treatment samplings of IV Clear™, Tegaderm™ CHG and Silicone control dressings collected. | Assessed after 4 days and 7 days of dressing application |
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Inclusion Criteria:
Exclusion Criteria:
Subjects will not be enrolled in the study if they:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis J Ward, D.O. | Hill Top Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hill Top Research | Miamiville | Ohio | 45147 | United States |
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| Tegaderm CHG™ | Device | Polyurethane film, polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate |
|
| Silicone Vehicle Control Dressing | Device | Polyurethane film with silicone adhesive dressing, without antimicrobials |
|