Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters
Infection

About this trial
This is an interventional prevention trial for Infection focused on measuring catheter site infection, catheter colonization, catheter related blood stream infection, patients with central venous catheters
Eligibility Criteria
Inclusion Criteria: New insertion of at least 1 noncuffed (nontunneled) temporary central venous catheter Males and females of at least 13 years of age A negative urine or serum pregnancy test at baseline Exclusion Criteria: Insertion of, or requirement for, any study catheter impregnated/bonded with an antimicrobial substance High probability of death within 14 days of enrollment as assessed by the investigator Prior treatment with vancomycin (intravenous administration only), daptomycin, linezolid, or quinupristin/dalfopristin, within 48 hours of first study catheter insertion or prior treatment with tigecycline within one week of first study catheter insertion Requirement for topical antibiotic use within 10 cm of any study catheterization site Known severe neutropenia (absolute neutrophil count [ANC] < 500 mm3) or recent administration of antineoplastic therapy expected to result in severe neutropenia within 48 hours of first study catheter insertion Routine non-complicated coronary artery bypass grafting (CABG) patients, bone marrow transplant (BMT) or solid organ transplant (SOT) patients Patients anticipated to be catheterized for less than 48 hours Patients who have a suspected or known bloodstream infection at enrollment Burn patients or patients with toxic epidermal necrolysis Known allergy to adhesive tape or adhesive bandages
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Povidone-Iodine 10%
omiganan 1% gel