Impact of Tegaderm HP and CHG in Major Catheter Related Infections and Dressing Detachment (DRESSING2)
Primary Purpose
Catheter-Related Infections
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Tegaderm, Tegaderm HP, Tegaderm CHG
Sponsored by
About this trial
This is an interventional prevention trial for Catheter-Related Infections focused on measuring catheter, dressing, chlorhexidine, Patient admitted in ICU with a CVC or art. catheter
Eligibility Criteria
Inclusion Criteria:
- patients older than 18 years old with a central venous catheter or arterial catheter installed in the study departement for a maximum for 24 hours
Exclusion Criteria:
- pulmonary arterial catheter
- antiseptic-impregnated catheter
- hemodialysis catheter
- chlorhexidine allergy
- emergency catheter without surgical asepsis
Sites / Locations
- University Hospital of Grenoble
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Tegaderm HP
Tegaderm
Tegaderm CHG
Arm Description
Outcomes
Primary Outcome Measures
Risk of major catheter infection between Group 1 and Group 2+3 assessed by an independent blind expert panel
The patients were followed 48h after catheter removal or discharge. Average follow up of 10 days.
Secondary Outcome Measures
dressing detachment : rate of unplanned dressing between Tegaderm CHG, Tegaderm HP and Tegaderm
Comparison of Group 1 to group 2+3 : catheter colonization, CR-BSI, cutaneous colonization at catheter removal, cost
Full Information
NCT ID
NCT01189682
First Posted
May 25, 2010
Last Updated
October 18, 2013
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT01189682
Brief Title
Impact of Tegaderm HP and CHG in Major Catheter Related Infections and Dressing Detachment
Acronym
DRESSING2
Official Title
Impact of Tegaderm HP and Tegaderm CHG in Major Catheter Related Infections and Dressing Detachment in ICU Patients a Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Catheter related infection is a frequent and life threatening event in ICU. A chlorhexidine impregnated sponge has been proven to reduce the rate of major catheter related infections in ICU patients (HR=0.39, p=0.03) (Timsit Jama 2009). However, dressings are detached in 40% of cases before planned changes and the rate of unplanned dressing is significantly associated with the major catheter related infections.
Primary objective: To demonstrate that Tegaderm CHG, a new CHG impregnated dressing decrease the rate of major catheter related infection as compared to non impregnated dressings and to demonstrate that highly adhesive dressing decrease the rate of detached dressings.
Secondary objectives:
To demonstrate that the use of high performance dressing decrease the rate of unstuck dressing and the rate of catheter infections.
To evaluate the tolerance of CHG impregnated gel dressings (Tegaderm CHG).
To calculate the cost saving of each dressings
Detailed Description
Inclusion criteria: Patients older than 18 years old with central venous who need a central vein and/or an arterial catheter for an expected duration of more than 48 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter-Related Infections
Keywords
catheter, dressing, chlorhexidine, Patient admitted in ICU with a CVC or art. catheter
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1960 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tegaderm HP
Arm Type
Active Comparator
Arm Title
Tegaderm
Arm Type
Placebo Comparator
Arm Title
Tegaderm CHG
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Tegaderm, Tegaderm HP, Tegaderm CHG
Other Intervention Name(s)
Tegaderm, Tegaderm HP, tegaderm CHG
Intervention Description
dressings on catheters
Primary Outcome Measure Information:
Title
Risk of major catheter infection between Group 1 and Group 2+3 assessed by an independent blind expert panel
Description
The patients were followed 48h after catheter removal or discharge. Average follow up of 10 days.
Time Frame
48 hours after catheter removal or ICU discharge (10 days on average)
Secondary Outcome Measure Information:
Title
dressing detachment : rate of unplanned dressing between Tegaderm CHG, Tegaderm HP and Tegaderm
Time Frame
until catheter removal or ICU discharge (8 days on average)
Title
Comparison of Group 1 to group 2+3 : catheter colonization, CR-BSI, cutaneous colonization at catheter removal, cost
Time Frame
48 hours after catheter removal or ICU discharge (10 days on average)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients older than 18 years old with a central venous catheter or arterial catheter installed in the study departement for a maximum for 24 hours
Exclusion Criteria:
pulmonary arterial catheter
antiseptic-impregnated catheter
hemodialysis catheter
chlorhexidine allergy
emergency catheter without surgical asepsis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TIMSIT Jean-François, PU/PH
Organizational Affiliation
Unit Intensive care
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Grenoble
City
Grenoble
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
35799302
Citation
Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.
Results Reference
derived
PubMed Identifier
32703235
Citation
Buetti N, Ruckly S, Schwebel C, Mimoz O, Souweine B, Lucet JC, Timsit JF. Chlorhexidine-impregnated sponge versus chlorhexidine gel dressing for short-term intravascular catheters: which one is better? Crit Care. 2020 Jul 23;24(1):458. doi: 10.1186/s13054-020-03174-0.
Results Reference
derived
PubMed Identifier
32643100
Citation
Buetti N, Ruckly S, Lucet JC, Bouadma L, Schwebel C, Mimoz O, Timsit JF. Ultrasound guidance and risk for intravascular catheter-related infections among peripheral arterial catheters: a post-hoc analysis of two large randomized-controlled trials. Ann Intensive Care. 2020 Jul 8;10(1):89. doi: 10.1186/s13613-020-00705-4.
Results Reference
derived
PubMed Identifier
26086783
Citation
Maunoury F, Motrunich A, Palka-Santini M, Bernatchez SF, Ruckly S, Timsit JF. Cost-Effectiveness Analysis of a Transparent Antimicrobial Dressing for Managing Central Venous and Arterial Catheters in Intensive Care Units. PLoS One. 2015 Jun 18;10(6):e0130439. doi: 10.1371/journal.pone.0130439. eCollection 2015.
Results Reference
derived
PubMed Identifier
24127770
Citation
Timsit JF, Bouadma L, Mimoz O, Parienti JJ, Garrouste-Orgeas M, Alfandari S, Plantefeve G, Bronchard R, Troche G, Gauzit R, Antona M, Canet E, Bohe J, Herrault MC, Schwebel C, Ruckly S, Souweine B, Lucet JC. Jugular versus femoral short-term catheterization and risk of infection in intensive care unit patients. Causal analysis of two randomized trials. Am J Respir Crit Care Med. 2013 Nov 15;188(10):1232-9. doi: 10.1164/rccm.201303-0460OC.
Results Reference
derived
PubMed Identifier
23043083
Citation
Timsit JF, Mimoz O, Mourvillier B, Souweine B, Garrouste-Orgeas M, Alfandari S, Plantefeve G, Bronchard R, Troche G, Gauzit R, Antona M, Canet E, Bohe J, Lepape A, Vesin A, Arrault X, Schwebel C, Adrie C, Zahar JR, Ruckly S, Tournegros C, Lucet JC. Randomized controlled trial of chlorhexidine dressing and highly adhesive dressing for preventing catheter-related infections in critically ill adults. Am J Respir Crit Care Med. 2012 Dec 15;186(12):1272-8. doi: 10.1164/rccm.201206-1038OC. Epub 2012 Oct 4.
Results Reference
derived
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Impact of Tegaderm HP and CHG in Major Catheter Related Infections and Dressing Detachment
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