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The purpose of this study is to determine whether contact sensitization occurs to the skin of normal healthy human subjects, by repetitive application of IV Clear™, Tegaderm CHG™ and Silicone Vehicle Control dressings.
A single center, within-subject randomized study design in healthy adult subjects. Qualified subjects will complete three phases of the study (induction, rest and challenge).
Data for irritation, adhesion and pain upon removal will be collected from the individual patch sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Clear™ | Experimental |
| |
| Tegaderm CHG™ | Active Comparator |
| |
| Control Vehicle Dressing | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Clear™ | Device | Polyurethane film with a silicone adhesive dressing containing chlorhexidine and silver |
|
| Measure | Description | Time Frame |
|---|---|---|
| Irritation | Irritation assessed at the induction phase will be scored on a Berger and Bowman Scale. Irritation assessed at the challenge phase will be scored on a defined scale measuring erythema reactions, ranging from no reaction to strong erythema. | Assessed at induction phase (evaluated before reapplication; 9 applications over 3 weeks, reapplied after every 48 or 72 hrs) and challenge phase (single 48-hr application of test article to naive sites and evaluation 30 mins, 24 and 48 hrs post-removal |
| Measure | Description | Time Frame |
|---|---|---|
| Adhesion | Adhesion was scored as follows: 0 = no lift from skin (≥90% adherence)
| Assessed at each 72 hour evaluation over three weeks, and once for a single 48-hour challenge application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Micah Humphrey, B.S. | Hill Top Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hill Top Research | St. Petersburg | Florida | 33710 | United States |
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| Tegaderm CHG™ | Device | Polyurethane film with a 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 |
|
| Pain upon removal | Any pain experienced during removal will be rated on a scale from 0 to 10, where 0 = no pain and 10 = worst possible pain. | Assessed by subjects at 72 hour evaluations over three weeks and a single 48-hour challenge application |