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Impact of Tegaderm HP and CHG in Major Catheter Related Infections and Dressing Detachment

NCT ID: NCT01189682

Last Updated: 2013-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1960 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Catheter-Related Infections

Keywords

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catheter dressing chlorhexidine Patient admitted in ICU with a CVC or art. catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tegaderm HP

Group Type ACTIVE_COMPARATOR

Tegaderm, Tegaderm HP, Tegaderm CHG

Intervention Type PROCEDURE

dressings on catheters

Tegaderm

Group Type PLACEBO_COMPARATOR

Tegaderm, Tegaderm HP, Tegaderm CHG

Intervention Type PROCEDURE

dressings on catheters

Tegaderm CHG

Group Type ACTIVE_COMPARATOR

Tegaderm, Tegaderm HP, Tegaderm CHG

Intervention Type PROCEDURE

dressings on catheters

Interventions

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Tegaderm, Tegaderm HP, Tegaderm CHG

dressings on catheters

Intervention Type PROCEDURE

Other Intervention Names

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Tegaderm Tegaderm HP tegaderm CHG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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TIMSIT Jean-François, PU/PH

Role: PRINCIPAL_INVESTIGATOR

Unit Intensive care

Locations

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University Hospital of Grenoble

Grenoble, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 36645531 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35799302 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32703235 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32643100 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26086783 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24127770 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23043083 (View on PubMed)

Other Identifiers

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2009-A01184-53

Identifier Type: -

Identifier Source: org_study_id