NCT01189682

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,960

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 27, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

October 21, 2013

Status Verified

September 1, 2012

Enrollment Period

1.2 years

First QC Date

May 25, 2010

Last Update Submit

October 18, 2013

Conditions

Catheter-Related Infections

Keywords

catheterdressingchlorhexidinePatient admitted in ICU with a CVC or art. catheter

Outcome Measures

Primary Outcomes (1)

  • 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.

    48 hours after catheter removal or ICU discharge (10 days on average)

Secondary Outcomes (2)

  • dressing detachment : rate of unplanned dressing between Tegaderm CHG, Tegaderm HP and Tegaderm

    until catheter removal or ICU discharge (8 days on average)

  • Comparison of Group 1 to group 2+3 : catheter colonization, CR-BSI, cutaneous colonization at catheter removal, cost

    48 hours after catheter removal or ICU discharge (10 days on average)

Study Arms (3)

Tegaderm HP

ACTIVE COMPARATOR
Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG

Tegaderm

PLACEBO COMPARATOR
Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG

Tegaderm CHG

ACTIVE COMPARATOR
Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG

Interventions

Tegaderm, Tegaderm HP, Tegaderm CHGPROCEDURE

dressings on catheters

Also known as: Tegaderm, Tegaderm HP, tegaderm CHG
TegadermTegaderm CHGTegaderm HP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pulmonary arterial catheter
  • antiseptic-impregnated catheter
  • hemodialysis catheter
  • chlorhexidine allergy
  • emergency catheter without surgical asepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Grenoble

Grenoble, France

Location

Related Publications (7)

  • Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Valette X, Daubin C, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable model predicting the required catheter dwell time among mechanically ventilated critically ill patients in three randomized trials. Ann Intensive Care. 2023 Jan 16;13(1):5. doi: 10.1186/s13613-023-01099-9.

    PMID: 36645531DERIVED

  • 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.

    PMID: 35799302DERIVED

  • 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.

    PMID: 32703235DERIVED

  • 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.

    PMID: 32643100DERIVED

  • 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.

    PMID: 26086783DERIVED

  • 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.

    PMID: 24127770DERIVED

  • 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.

    PMID: 23043083DERIVED

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • TIMSIT Jean-François, PU/PH

    Unit Intensive care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2010

First Posted

August 27, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 21, 2013

Record last verified: 2012-09

Locations

FR(1)