Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231153
Status:
COMPLETED
Last Update Posted:
2009-08-13
First Post:
2005-10-03
Brief Title:
Study of Omiganan 1 Gel in Preventing Catheter InfectionsColonization in Patients With Central Venous Catheters
Sponsor:
Cadence Pharmaceuticals
Organization:
Cadence
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Evaluation Committee-Blinded Study to Assess the Efficacy of Topical Omiganan 1 Gel in Preventing Local Catheter Site InfectionsColonization in Patients Undergoing Central Venous Catheterization
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether treatment with topical omiganan is more effective than treatment with topical povidone-iodine in preventing local catheter site infections and catheter colonization in patients who have central venous catheters
Detailed Description:
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
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 eg bonded catheters antimicrobial impregnated silver tipped etc may be used as study catheters Study catheters must have a skincatheter 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 andor 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 gel group will receive an application of omiganan 1 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 andor site paintenderness
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 dischargewithdrawal for safety follow-up purposes
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
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 eg bonded catheters antimicrobial impregnated silver tipped etc may be used as study catheters Study catheters must have a skincatheter 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 andor 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 gel group will receive an application of omiganan 1 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 andor site paintenderness
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 dischargewithdrawal for safety follow-up purposes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT Number 2005-003194-24 | None | None | None |