Ignite Creation Date:
2024-05-06 @ 12:25 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03757143
Status:
COMPLETED
Last Update Posted:
2019-10-31
First Post:
2018-11-27
Brief Title:
Chlorhexidine-Alcohol Versus Povidone Iodine-Alcohol Combined or Not With Use of a Bundle of New Devices for Prevention of Intravascular-catheter Colonization and Catheter Failure
Sponsor:
Poitiers University Hospital
Organization:
Poitiers University Hospital
Study Overview
Official Title:
Skin Antisepsis With Chlorhexidine-Alcohol Versus Povidone Iodine-Alcohol Combined or Not With Use of a Bundle of New Devices for Prevention of Intravascular-catheter Colonization and Catheter Failure An Open Label Single Center Randomized Controlled Two-by-two Factorial Trial
Status:
COMPLETED
Status Verified Date:
2019-10
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:
CLEAN3
Brief Summary:
Short peripheral intravenous catheters PVC are the most frequently used invasive medical devices in hospitals Unfortunately PVCs often fail before the end of treatment due to the occurrence of complications which can be mechanical vascular or infectious Complications lead to infusion failure and device replacement which results in interrupted therapy pain associated with resiting and increased health care costs for resources and staff time Catheter related bloodstream infections CR-BSIs prolong hospitalization and increase treatment costs and mortality
Prevention of these complications is based on the respect of hygiene rules and the use of bio-compatible catheters The choice of the antiseptic solution for skin disinfection is key Similarly the use of new technologies such as catheters designed to minimize blood exposure zero-reflux needleless-connectors disinfecting caps and flushing PVCs before and after each medication administration to maintain catheter patency are of theoretical interest but little scientific data support their use in routine
The primary objectives of this study are first to demonstrate that skin preparation with 2 chlorhexidine CHG-70 isopropanol decreases the risk of PVC colonization compared to skin preparation with 5 povidone iodine PVI-69 ethanol Second to demonstrate that use of a bundle of technologies including a new PVC zero-reflux needless-connectors disinfecting caps and single-use prefilled flush syringes extends the time between catheter insertion and catheter failure
The secondary objectives are to compare between the four study group incidence of phlebitis accidental catheter removal infiltration catheter occlusion CR-BSI local infection all-cause bloodstream infections catheter colonization duration of catheter remaining in place without complication length of hospital stay safety and patient satisfaction
The CLEAN 3 study is an open-label single centre investigator-initiated randomised four-parallel group two-by-two factorial trial Patients requiring PVC for an expected 48 h will be randomised in one of four groups according to skin disinfection method and type of devices used Randomization will be carried out through a secure web-based randomization system Inclusions are expected to begin in January 2019 and continue until July 2019 once the number of catheters required has been reached
Patients will be enrolled at the Emergency department of the Poitiers University Hospital before being hospitalised in one of five wards neurology neurology pneumology internal medicine and downstream emergency unit
Prevention of these complications is based on the respect of hygiene rules and the use of bio-compatible catheters The choice of the antiseptic solution for skin disinfection is key Similarly the use of new technologies such as catheters designed to minimize blood exposure zero-reflux needleless-connectors disinfecting caps and flushing PVCs before and after each medication administration to maintain catheter patency are of theoretical interest but little scientific data support their use in routine
The primary objectives of this study are first to demonstrate that skin preparation with 2 chlorhexidine CHG-70 isopropanol decreases the risk of PVC colonization compared to skin preparation with 5 povidone iodine PVI-69 ethanol Second to demonstrate that use of a bundle of technologies including a new PVC zero-reflux needless-connectors disinfecting caps and single-use prefilled flush syringes extends the time between catheter insertion and catheter failure
The secondary objectives are to compare between the four study group incidence of phlebitis accidental catheter removal infiltration catheter occlusion CR-BSI local infection all-cause bloodstream infections catheter colonization duration of catheter remaining in place without complication length of hospital stay safety and patient satisfaction
The CLEAN 3 study is an open-label single centre investigator-initiated randomised four-parallel group two-by-two factorial trial Patients requiring PVC for an expected 48 h will be randomised in one of four groups according to skin disinfection method and type of devices used Randomization will be carried out through a secure web-based randomization system Inclusions are expected to begin in January 2019 and continue until July 2019 once the number of catheters required has been reached
Patients will be enrolled at the Emergency department of the Poitiers University Hospital before being hospitalised in one of five wards neurology neurology pneumology internal medicine and downstream emergency unit
Detailed Description:
None
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