Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00288418
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2006-02-06
Brief Title:
Safety and Efficacy Study of Angiotech Central Venous Catheter to Prevent Bacterial Catheter Colonization
Sponsor:
Angiotech Pharmaceuticals
Organization:
Angiotech Pharmaceuticals
Study Overview
Official Title:
A Controlled Randomized Single-Blind Multi-Center Pivotal Clinical Study Using Angiotech CVC to Prevent Bacterial Colonization on Short-Term Central Venous Catheters
Status:
COMPLETED
Status Verified Date:
2013-01
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 main purpose of this study is to determine if the Angiotech central venous catheter CVC is equal in effectiveness to a CVC coated with chlorhexidine and silver sulfadiazine in preventing bacterial catheter colonization Other objectives of this study are to determine if the Angiotech CVC is equal in effectiveness to a CVC coated with chlorhexidine and silver sulfadiazine in preventing catheter-related local infection and catheter-related bloodstream infection This study will also assess the safety of the Angiotech CVC
Detailed Description:
Central venous catheters are widely used for hemodynamic monitoring and the administration of fluids drugs and nutrition The most frequent life-threatening complication of central venous catheter use is septicemia Normal cutaneous flora may invade the intracutaneous tract during or after catheter insertion The colonizing bacteria subsequently disseminate along the catheter surface and ultimately seed into the blood stream
In the United States a total of 250000 cases of central venous catheter-related infections are estimated annually Costs per infection are estimated as high as US56000 It is clinically imperative that effective measures be found to decrease catheter infection rates while minimizing the risk of the development of microbial resistance
Primary Objective The primary objective of this study is to determine the non-inferiority of the Angiotech Central Venous Catheter CVC when compared to the ARROWgard Blue CVC to prevent bacterial catheter colonization
Secondary Objectives The secondary objectives of this study are to determine the non-inferiority of the Angiotech CVC when compared to the ARROWgard Blue CVC to prevent
1 catheter-related local infection and
2 catheter-related bloodstream infection
Safety Objectives This study will assess the safety of the Angiotech CVC
In the United States a total of 250000 cases of central venous catheter-related infections are estimated annually Costs per infection are estimated as high as US56000 It is clinically imperative that effective measures be found to decrease catheter infection rates while minimizing the risk of the development of microbial resistance
Primary Objective The primary objective of this study is to determine the non-inferiority of the Angiotech Central Venous Catheter CVC when compared to the ARROWgard Blue CVC to prevent bacterial catheter colonization
Secondary Objectives The secondary objectives of this study are to determine the non-inferiority of the Angiotech CVC when compared to the ARROWgard Blue CVC to prevent
1 catheter-related local infection and
2 catheter-related bloodstream infection
Safety Objectives This study will assess the safety of the Angiotech CVC
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