Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-02-20 @ 4:32 PM
Study NCT ID:
NCT02446158
Status:
COMPLETED
Last Update Posted:
2015-05-18
First Post:
2015-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients
Sponsor:
E-DA Hospital
Organization:
Study Overview
Official Title:
A Randomized Trial of Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients for Bacterial Decolonization and Prevention of Infection
Status:
COMPLETED
Status Verified Date:
2015-05
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:
Chlorhexidine is used in central line dressing changes and is effective in reducing line infections. It is unclear if daily chlorhexidine care at the exit site in peritoneal dialysis (PD) patients can reduce the risk of Staphylococcus aureus (SA) colonization or exit site infection.
Detailed Description:
There is no consensus on what regimen is optimal for topical care of the peritoneal dialysis (PD) catheter exit site. Several methods including soap and water, povidone-iodine, hydrogen peroxide, chlorhexidine, and topical antimicrobial agents such as gentamicin or mupirocin cream have been described for care of the exit site. However, many of these studies were small or short-term and lacked longitudinal evaluation of bacterial decolonization efficacy. Staphylococcus aureus (SA) is one of most common causes of peritonitis and exit-site infection and is associated with a high PD catheter removal rate. Carriers of SA had a higher rate of exit-site infection than non-carriers. In previous studies, staphylococcal carriage prophylaxis using either mupirocin or gentimicin ointment in the nares or exit site significantly reduced the rate of exit-site infection due to SA. However, emerging antibiotic resistance is a concern. In addition, MRSA infection in PD patients is more severe than other pathogens; therefore, choosing a good antiseptic for SA and/or MRSA decolonization is important.
In recent years, the use of chlorhexidine in bathing or central line dressing changes was implemented to prevent bacterial colonization and multidrug resistant bacterial infections and was also used in hemodialysis patients. Data regarding chlorhexidine used in the catheter care of PD patients are limited and it is unclear if the use of chlorhexidine for exit site care contributes to long-term bacterial decolonization and acts as a prophylaxis for exit site infections.
In recent years, the use of chlorhexidine in bathing or central line dressing changes was implemented to prevent bacterial colonization and multidrug resistant bacterial infections and was also used in hemodialysis patients. Data regarding chlorhexidine used in the catheter care of PD patients are limited and it is unclear if the use of chlorhexidine for exit site care contributes to long-term bacterial decolonization and acts as a prophylaxis for exit site infections.
Study Oversight
Has Oversight DMC:
True
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?: