NCT00417235

Brief Summary

The purpose of this study is to determine whether a catheter dressing every 7th day is not inferior to a catheter dressing every 3 days and if Chlorhexidine impregnated sponges are effective in preventing catheter-related infections in ICUs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

December 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2006

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

May 24, 2016

Status Verified

June 1, 2008

Enrollment Period

1.4 years

First QC Date

December 28, 2006

Last Update Submit

May 23, 2016

Conditions

Systemic Inflammatory Response SyndromeBacteremia

Keywords

catheter related infectioncatheter dressingpreventionChlorhexidine impregnated dressingsInfectioncatheterization

Outcome Measures

Primary Outcomes (2)

  • Systemic catheter related sepsis as defined by a blinded expert panels to unmask differences between Chlorhexidine dressings and no Chlorhexidine dressings

    48 hours

  • Significant catheter culture >=103 cfu/ml for non inferiority between 7 days and 3 day catheter-dressing frequencies

    48 hours

Secondary Outcomes (3)

  • catheter related septicemia

    48 hours

  • cutaneous allergy

    24 hours

  • cost

    within the 60 days after catheter insertion

Study Arms (4)

3-days dressing frequency/CHX sponge

EXPERIMENTAL

Interventions: Device: 'Chlorhexidine Sponge (Biopatch TM)' on the insertion site

Device: Chlorhexidine Sponge (Biopatch TM)

7-days dressing frequency/CHX sponge

EXPERIMENTAL

Interventions: Behavioural: 7-day catheter dressing frequency Device: 'Chlorhexidine Sponge (Biopatch TM)' on the insertion site

Device: Chlorhexidine Sponge (Biopatch TM)Behavioral: 7-day catheter dressing frequency

3-days dressing frequency/No CHX sponge

NO INTERVENTION

No intervention, classical protocol of dressing frequency every 3-days and no other device

7-days dressing change/No CHX sponge

EXPERIMENTAL

Interventions:Behavioural: 7-day catheter dressing frequency

Behavioral: 7-day catheter dressing frequency

Interventions

Chlorhexidine Sponge (Biopatch TM)DEVICE

dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge

3-days dressing frequency/CHX sponge7-days dressing frequency/CHX sponge
7-day catheter dressing frequencyBEHAVIORAL

dressing changes every 7 days versus every classical change every 3 days

7-days dressing change/No CHX sponge7-days dressing frequency/CHX sponge

Eligibility Criteria

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

You may qualify if:

  • patients older than 18 years
  • with at least a central venous catheter or an arterial catheter
  • whatever the first or subsequent CVC in a same patient
  • in any site of insertion (sub-clavian, jugular or femoral)
  • whatever le CVC is tunnelled or not
  • CVC inserted in the study ICU or immediately before by the intensisvist in the emergency unit or in the operative room,
  • CVC inserted under maximal barrier precautions

You may not qualify if:

  • pulmonary artery catheter, haemodialysis/haemodiafiltration CVCs
  • known allergy to chlorhexidine
  • CVC not inserted under maximal barrier precautions
  • Expected duration of CVC for less than 48 hours
  • CVC inserted under emergency conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

grenoble university hospital (medical ICU and surgical ICU)

Grenoble, 38043, France

Location

Saint Joseph Hospital

Paris, 75014, France

Location

University Hospital Beaujon

Paris, 75018, France

Location

University hospital Bichat Claude Bernard

Paris, 75018, France

Location

Related Publications (5)

  • 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

  • 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, Bouadma L, Ruckly S, Schwebel C, Garrouste-Orgeas M, Bronchard R, Calvino-Gunther S, Laupland K, Adrie C, Thuong M, Herault MC, Pease S, Arrault X, Lucet JC. Dressing disruption is a major risk factor for catheter-related infections. Crit Care Med. 2012 Jun;40(6):1707-14. doi: 10.1097/CCM.0b013e31824e0d46.

    PMID: 22488003DERIVED

  • Schwebel C, Lucet JC, Vesin A, Arrault X, Calvino-Gunther S, Bouadma L, Timsit JF. Economic evaluation of chlorhexidine-impregnated sponges for preventing catheter-related infections in critically ill adults in the Dressing Study. Crit Care Med. 2012 Jan;40(1):11-7. doi: 10.1097/CCM.0b013e31822f0604.

    PMID: 21926570DERIVED

  • Timsit JF, Schwebel C, Bouadma L, Geffroy A, Garrouste-Orgeas M, Pease S, Herault MC, Haouache H, Calvino-Gunther S, Gestin B, Armand-Lefevre L, Leflon V, Chaplain C, Benali A, Francais A, Adrie C, Zahar JR, Thuong M, Arrault X, Croize J, Lucet JC; Dressing Study Group. Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults: a randomized controlled trial. JAMA. 2009 Mar 25;301(12):1231-41. doi: 10.1001/jama.2009.376.

    PMID: 19318651DERIVED

MeSH Terms

Conditions

Systemic Inflammatory Response SyndromeBacteremiaCatheter-Related InfectionsInfections

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockBacterial InfectionsBacterial Infections and MycosesSepsis

Study Officials

  • jean-francois Timsit

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

  • jean-christophe Lucet, MD

    University hospital Bichat, Paris, France

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 28, 2006

First Posted

December 29, 2006

Study Start

January 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

May 24, 2016

Record last verified: 2008-06

Locations

FR(4)