Study of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects
|Infection||Drug: omiganan 1% gel Drug: chlorhexidine 2% solution||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Single- Center, Open-Label, Study of the Persistence of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects|
- Change in Mean Number of Skin Bacterial Counts From Baseline to 72 Hours [ Time Frame: Prior to first application (0 hours) to 72 hours post application ]
- Change in Mean Number of Skin Bacterial Counts From Baseline to 7 Days [ Time Frame: Prior to first application (0 hours) to 7 days post application. ]
- Number of Subjects With Significantly Colonized Catheters, Defined as > or = to 15 Colony Forming Units- CFUs) [ Time Frame: Each sampling point and the rate of catheter colonization for each treatment 72 hours to 7 days. ]
|Study Start Date:||May 2008|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Experimental: omiganan 1% gel
Omiganan has a rapid bactericidal and fungicidal effect which is under development for the prevention of infections arising from short-term central venous catheters, as well as for the prevention of surgical wound infections in contaminated wounds.
Drug: omiganan 1% gel
Omiganan 1% gel will be applied to 6 sites on the chest and/or abdomen.Swab cultures will be obtained at specified timepoints over a period of 3 days (Part1) or 7 days (Part 2).
In addition, subjects in Part 2 will have omiganan 1% gel applied to one intravenous (IV) catheter site.
|Active Comparator: chlorhexidine 2%||
Drug: chlorhexidine 2% solution
Part 1- chlorhexidine 2% solution will be applied to 6 sites on the chest and/or abdomen. All application sites will be covered with semi-transparent dressings.Swab cultures will be obtained at specific timepoints over a period of 3 days.
Part 2: Subjects in Part 2 will have chlorhexidine 2% solution applied to one intravenous (IV) catheter site only.
The study is comprised of 2 parts with approximately 20 subjects participating in each part.
Subjects eligible for Part 1 will have omiganan 1 % gel applied to 6 sites across the chest and/or abdomen and chlorhexidine 2% solution will be applied to 6 matching sites on the contralateral side.
Subjects eligible for Part 2 will each have omiganan 1% gel applied to 6 sites across the upper chest or abdomen.In addition,subjects in Part 2 will have 2 peripheral catheters inserted, one in each arm.One catheter insertion site will be treated with omiganan 1% gel (following treatment with isopropyl alcohol) and the other site will be treated with chlorhexidine 2%/isopropyl alcohol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608959
|United States, Montana|
|Bozeman, Montana, United States, 59715|
|Study Director:||Catherine J Hardalo, MD||Mallinckrodt|