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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
216
Polyurethane film with a silicone adhesive dressing containing chlorhexidine and silver
Polyurethane film with a polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate
Polyurethane film with silicone adhesive dressing, without antimicrobials
Hill Top Research
St. Petersburg, Florida, United States
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.
Time frame: 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
Adhesion
Adhesion was scored as follows: 0 = no lift from skin (≥90% adherence) 1. = some edges only lifting from skin (≥75% to ˂90% adherence) 2. = less than half of the test article lifing (≥50% to ˂75% adherence) 3. = more than half of the test article lifing but not detached (≥25% to ˂50% adherence) 4. = test article detached (0% adherence)
Time frame: 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.
Time frame: Assessed by subjects at 72 hour evaluations over three weeks and a single 48-hour challenge application
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