Study of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects
|ClinicalTrials.gov Identifier: NCT00608959|
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : January 25, 2010
Last Update Posted : January 26, 2010
|Condition or disease||Intervention/treatment||Phase|
|Infection||Drug: omiganan 1% gel Drug: chlorhexidine 2% solution||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
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.
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608959
|United States, Montana|
|Bozeman, Montana, United States, 59715|
|Study Director:||Catherine J Hardalo, MD||Mallinckrodt|