• To demonstrate the effectiveness of omiganan 1.0% gel compared to 10% povidone-iodine in preventing local catheter site infections in patients requiring at least one central venous catheter [ Time Frame: study completion ] [ Designated as safety issue: No ]
  

• Clinically diagnosed local catheter site infection (LCSI) or death [ Time Frame: study completion ] [ Designated as safety issue: No ]
  
• clinically diagnosed LCSI in the intent-to-treat (ITT) analysis set [ Time Frame: study completion ] [ Designated as safety issue: No ]
  
• microbiologically-confirmed LCSI [ Time Frame: study completion ] [ Designated as safety issue: No ]
  
• catheter-related bloodstream infections (CRBSI) [ Time Frame: study completion ] [ Designated as safety issue: No ]
  
• bloodstream infections (BSI) [ Time Frame: study completion ] [ Designated as safety issue: No ]
  
• catheter colonization [ Time Frame: study completion ] [ Designated as safety issue: No ]
  

Drug: Omiganan 1% gel
Omiganan gel will be applied around the catheter insertion site following catheter insertion for those patients randomized to group A. Every 3 days the dressing will be changed and patients will receive a new application of Omiganan 1% gel.

Study design:

This is a phase 3, multi-center, randomized, Evaluation Committee-blinded study in patients undergoing noncuffed central venous catheterization using either a single lumen or multi-lumen catheter, and for whom the catheter is expected to be in place for at least 48 hours and for no longer than 28 days.

Patients will be randomized within 4 hours of the insertion of the first study CVC. At the time that the first study CVC is inserted, it is permissible for non-study CVC, PICC, and/or arterial catheters to be in place as long as they are removed within 8 hours of their respective insertion(s).

The first study catheter for all patients must be a noncuffed (nontunneled) central venous catheter (CVC). Additionally, only catheters inserted using povidone iodine to prepare the insertion site are eligible to become study catheters. CVCs will be inserted either into the axillary, jugular, subclavian, or femoral vein. Following the first study CVC insertion, additional CVCs, as well as arterial catheters and PICC lines will be allowed as study catheters. Only catheters that have not been impregnated with an antimicrobial substance (e.g. bonded catheters, antimicrobial impregnated, silver tipped, etc) may be used as study catheters. Study catheters must have a skin/catheter interface; for example, introducers will be allowed as study catheters but any catheter, including a CVC, inserted through the introducer will be deemed a non-study catheter. Once a patient has been randomized to either treatment, all study catheters will receive the same treatment.

NIH (NCID) and/or local hospital guidelines will be followed for maximal sterile barrier precautions. The catheter site will be disinfected using 10% povidone iodine for a minimum of 2 minutes per established CDC guidelines prior to catheter insertion. Patients randomized to the omiganan 1.0% gel group will receive an application of omiganan 1.0% gel around the catheter insertion site following catheter insertion. Patients randomized to the povidone iodine group will receive no further antisepsis treatment other than cleansing the site with povidone iodine at dressing changes. For patients in both groups, the catheterization site will be covered with a semitransparent dressing provided by the sponsor.

Every 3 days the dressing will be changed. Skin irritation, erythema and edema will be assessed as well as the presence of purulence, moisture, ecchymosis, abnormally warm tissue temperature and/or site pain/tenderness.

Patients will be discharged from the study following the removal of the final study catheter or on study day 28, whichever is sooner. Patients or their legal representatives will be contacted at least 28 days after study discharge/withdrawal for safety follow-up purposes.