Antimicrobial Activity of IV Clear™ Dressing - Prevention of Antimicrobial Regrowth
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|ClinicalTrials.gov Identifier: NCT01368120|
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : April 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Skin Flora Infection||Device: IV Clear™ Dressing Device: Tegaderm CHG™ Device: Silicone Vehicle Control Dressing||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||April 2011|
|Primary Completion Date :||July 2011|
|Study Completion Date :||July 2011|
|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
- 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.
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): NCT01368120
|United States, Ohio|
|Hill Top Research|
|Miamiville, Ohio, United States, 45147|
|Principal Investigator:||Dennis J Ward, D.O.||Hill Top Research|