Human Repeat Insult Patch Test of Wound Dressings

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Skin Sensitization

Intervention / Treatment
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* Device: IV Clear™
* Device: Tegaderm CHG™
* Device: Silicone Vehicle Control Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18 years or older 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: Subject pregnant, planning a pregnancy or lactating 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV Clear™<br> | Device: IV Clear™<br>* Polyurethane film with a silicone adhesive dressing containing chlorhexidine and silver<br>|
| Active Comparator: Tegaderm CHG™<br> | Device: Tegaderm CHG™<br>* Polyurethane film with a polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate<br>|
| Placebo Comparator: Control Vehicle Dressing<br> | Device: Silicone Vehicle Control Dressing<br>* Polyurethane film with silicone adhesive dressing, without antimicrobials<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhesion | Adhesion was scored as follows: 0 = no lift from skin (≥90% adherence) = some edges only lifting from skin (≥75% to ˂90% adherence) = less than half of the test article lifing (≥50% to ˂75% adherence) = more than half of the test article lifing but not detached (≥25% to ˂50% adherence) = test article detached (0% adherence) | Assessed at each 72 hour evaluation over three weeks, and once for a single 48-hour challenge application | 
| 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 |