Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04800575
Status:
UNKNOWN
Last Update Posted:
2021-09-23
First Post:
2021-03-09
Brief Title:
Comparison of Sterile Gauze and Semi-permeable Film Dressing for Hemodialysis Central Venous Catheter
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
Comparison of the Efficacy of Sterile Gauze and Semi-permeable Film Dressing for Hemodialysis Non-tunneling Central Venous Catheter
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
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:
This prospective single center RCT aims to compare sterile gauze and tape versus Semi-permeable film dressing on the incidence of exit-site infection CRBSIs catheter-related bloodstream infections skin irritation total bacterial count dressing intactness and cost-benefit nursing workload in hemodialysis patients with a non-tunneled hemodialysis catheter
Detailed Description:
This prospective single center RCT aims to compare sterile gauze and tape versus Semi-permeable film dressing on the incidence of exit-site infection CRBSIs catheter-related bloodstream infections skin irritation total bacterial count dressing intactness and cost-benefit nursing workload in hemodialysis patients with a non-tunneled hemodialysis catheter
154 eligible patients in our HD center will be enrolled consecutively and randomly allocated to one of the two groups according to computer-generated randomization sequences in a 11 ratio Experiment group use semi-permeable film as dressing in exit-site of CVC and a sterile gauze and tape in control group Both groups share same disinfection and dressing change procedure Dressings will be replaced per hemodialysis session or as needed Socio-demographic data and disease-related information will be collected as well as catheterization site physician skin and exit status of the catheterization site at baseline Data as listed in the beginning will be recorded in the next 2 weeks follow-up at every session such as sign of exit-site infection CRBSIs catheter-related bloodstream infections skin irritation and dryness dressing intactness Before the 2nd dressing change skin around exit of CVC under dressing area will be swabbed by a cotton swab Nursing time of dressing change will be recorded by a third nurses Cost and benefit will be calculated and compared by the end
154 eligible patients in our HD center will be enrolled consecutively and randomly allocated to one of the two groups according to computer-generated randomization sequences in a 11 ratio Experiment group use semi-permeable film as dressing in exit-site of CVC and a sterile gauze and tape in control group Both groups share same disinfection and dressing change procedure Dressings will be replaced per hemodialysis session or as needed Socio-demographic data and disease-related information will be collected as well as catheterization site physician skin and exit status of the catheterization site at baseline Data as listed in the beginning will be recorded in the next 2 weeks follow-up at every session such as sign of exit-site infection CRBSIs catheter-related bloodstream infections skin irritation and dryness dressing intactness Before the 2nd dressing change skin around exit of CVC under dressing area will be swabbed by a cotton swab Nursing time of dressing change will be recorded by a third nurses Cost and benefit will be calculated and compared by the end
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None