Study of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects
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|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. ]
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): NCT00608959
|United States, Montana|
|Bozeman, Montana, United States, 59715|
|Study Director:||Catherine J Hardalo, MD||Mallinckrodt|