Antimicrobial Activity of IV Clear™ Dressing - Prevention of Antimicrobial Regrowth
|Skin Flora Infection||Device: IV Clear™ Dressing Device: Tegaderm CHG™ Device: Silicone Vehicle Control Dressing||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
- Change in skin microbial colonization over 7-day period of antimicrobial dressing application [ Time Frame: Assessed after 4 days and 7 days of 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.
|Study Start Date:||April 2011|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
|Experimental: IV Clear™||
Device: IV Clear™ Dressing
Polyurethane film, silicone adhesive dressing with chlorhexidine and silver
|Active Comparator: Tegaderm CHG™||
Device: Tegaderm CHG™
Polyurethane film, polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate
|Placebo Comparator: Vehicle Control Dressing||
Device: Silicone Vehicle Control Dressing
Polyurethane film with silicone adhesive dressing, without antimicrobials
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368120
|United States, Ohio|
|Hill Top Research|
|Miamiville, Ohio, United States, 45147|
|Principal Investigator:||Dennis J Ward, D.O.||Hill Top Research|