Human Repeat Insult Patch Test of Wound Dressings
|ClinicalTrials.gov Identifier: NCT01368146|
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : April 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Skin Sensitization||Device: IV Clear™ Device: Tegaderm CHG™ Device: Silicone Vehicle Control Dressing||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2011|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
|Experimental: IV Clear™||
Device: IV Clear™
Polyurethane film with a silicone adhesive dressing containing chlorhexidine and silver
|Active Comparator: Tegaderm CHG™||
Device: Tegaderm CHG™
Polyurethane film with a polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate
|Placebo Comparator: Control Vehicle Dressing||
Device: Silicone Vehicle Control Dressing
Polyurethane film with silicone adhesive dressing, without antimicrobials
- Irritation [ 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 ]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.
- Adhesion [ Time Frame: Assessed at each 72 hour evaluation over three weeks, and once for a single 48-hour challenge application ]
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)
- Pain upon removal [ Time Frame: Assessed by subjects at 72 hour evaluations over three weeks and a single 48-hour challenge application ]Any pain experienced during removal will be rated on a scale from 0 to 10, where 0 = no pain and 10 = worst possible pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368146
|United States, Florida|
|Hill Top Research|
|St. Petersburg, Florida, United States, 33710|
|Principal Investigator:||Micah Humphrey, B.S.||Hill Top Research|