Source: https://ichgcp.net/es/clinical-trials-registry/NCT00608959
Timestamp: 2020-05-27 15:00:40
Document Index: 165309540

Matched Legal Cases: ['art1', 'art 2', 'art 2', 'art 1', 'art 2', 'art 2']

Study of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects - ICH GCP - Clinical Trials Registry
Prior to first application (0 hours) to 72 hours post application
Prior to first application (0 hours) to 7 days post application.
Each sampling point and the rate of catheter colonization for each treatment 72 hours to 7 days.
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.
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.
Catherine Hardalo, MD. Vice President, Anti Infectives Clinical Development
Cadence Pharmaceuticals,Inc.
Skin colonization , Catheter colonization , Catheter site infection