Ignite Creation Date:
2024-05-06 @ 3:23 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02277171
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2014-10-19
Brief Title:
Evaluation of Safety and Tolerability of Nitric Oxide Impregnated Urinary Catheters
Sponsor:
Enox Israel Ltd
Organization:
Enox Israel Ltd
Study Overview
Official Title:
Prospective Phase I Single-Center Evaluation of the Safety and Tolerability of Nitric Oxide Impregnated Urinary Catheters in Patients Undergoing Radical Prostatectomy
Status:
COMPLETED
Status Verified Date:
2015-12
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:
According to the World Health Organization hundreds of millions of patients are affected by health-care associated infections worldwide each year resulting in prolonged hospital stays long-term disabilities deaths and financial losses for health systems The most common hospital-acquired infection is Urinary Tract Infection UTI accounting for almost 40 of all nosocomial infections Most hospital-acquired UTIs are associated with catheterization In fact urinary catheter-related bacteriuria is the most common health care associated infection worldwide Catheter-associated UTI CAUTI develops following adhesion of planktonic bacteria to the surface of the catheter and colonization creating a persistent environment called a biofilm The nature of biofilm structure together with the physiological attributes of biofilm organisms confers an inherent resistance to various antimicrobial agents such as antibiotics disinfectants or germicides augmenting the potential of these pathogens to cause infections in catheterized patients
Nitric oxide NO is a naturally-produced gas molecule with broad-spectrum antimicrobial activity NO is used in the clinics to treat pulmonary hypertension in neonates and adults Studies have shown that low-dose NO is associated with prevention of biofilm formation biofilm dispersal and elimination of bacteria It is suggested that NO prevents bacteria attachment to catheter surfaces and inhibits biofilm formation in a mechanism involving reduction and modification of proteins that mediate cell-substrate and cell-cell interactions
The investigators team using a proprietary technology impregnate urinary catheters with NO ie NO-impregnated catheters These catheters release low concentration of NO following exposure to urine over a 14-day period In vitro studies showed that NO-impregnated catheters prevent bacterial colonization and biofilm formation of Escherichia coli on exterior and luminal surfaces of the catheters In addition NO released from these catheters is able to eradicate up to 4log colony forming unitml of bacteria within the surrounding media Moreover NO-impregnated catheters exhibit superior performance compared to silver-coated catheters and similar anti-infective properties compared to antibiotic-coated catheters
Primary objectives To assess the safety and tolerability of NO-impregnated catheters in patients older than 18 years old undergoing radical prostatectomy and catheterized for 7-14 days
Nitric oxide NO is a naturally-produced gas molecule with broad-spectrum antimicrobial activity NO is used in the clinics to treat pulmonary hypertension in neonates and adults Studies have shown that low-dose NO is associated with prevention of biofilm formation biofilm dispersal and elimination of bacteria It is suggested that NO prevents bacteria attachment to catheter surfaces and inhibits biofilm formation in a mechanism involving reduction and modification of proteins that mediate cell-substrate and cell-cell interactions
The investigators team using a proprietary technology impregnate urinary catheters with NO ie NO-impregnated catheters These catheters release low concentration of NO following exposure to urine over a 14-day period In vitro studies showed that NO-impregnated catheters prevent bacterial colonization and biofilm formation of Escherichia coli on exterior and luminal surfaces of the catheters In addition NO released from these catheters is able to eradicate up to 4log colony forming unitml of bacteria within the surrounding media Moreover NO-impregnated catheters exhibit superior performance compared to silver-coated catheters and similar anti-infective properties compared to antibiotic-coated catheters
Primary objectives To assess the safety and tolerability of NO-impregnated catheters in patients older than 18 years old undergoing radical prostatectomy and catheterized for 7-14 days
Detailed Description:
None
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