Impact of ECMO Cannula Chlorhexidine-impregnated Dressings to Decrease Extracorporeal Membrane Oxygenation-cannula Related Infection Rate (DRESSING-ECMO)

November 20, 2025 updated by: Assistance Publique - Hôpitaux de Paris
The Dressing-ECMO trial is a prospective, open-label, multicenter, controlled trial randomizing patients who received percutaneous ECMO to cannula chlorhexidine-impregnated dressing vs standard dressing. The study goal is to determine if cannula chlorhexidine-impregnated dressings can reduce the number of cannula major-related infections with or without bloodstream infection

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open-label, multicenter, randomized, controlled trial. This study will be conducted in patients with cardiogenic shock or acute respiratory distress syndrome receiving percutaneous ECMO for less than 24h. All consecutive eligible patients will be proposed to participate. They will be randomly allocated in a 1:1 ratio to conventional cannula dressing, or cannula chlorhexidine-impregnated dressing, using an online, central randomisation service, to ensure allocation concealment. Blocked randomization will be performed using random block size. Randomization will be stratified according to center and ECMO type (i.e veno venous or arteriovenous). In both groups, peripheral blood sample will be cultured daily from first day on ECMO to 48h after ECMO removal, death on ECO or ECMO day 30 whichever occurs first. In case of ECMO cannula infection suspicion, deep samples of the cannula will be cultured according to the usual procedure.

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • CHU Besançon - Hôpital Jean Minjoz
      • Corbeil-Essonnes, France, 91100
        • Ch Sud Francilien
      • Créteil, France, 94000
        • Hôpital Henri-Mondor
      • Nancy, France, 54500
        • Chru Nancy - Hopitaux de Brabois
      • Paris, France, 75013
        • Hopital Pitie Salpetriere
      • Suresnes, France, 92150
        • Hopital FOCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with cardiogenic shock or refractory acute respiratory distress syndrome ECMO VA or VV ECMO for less than 24 hours.
  • ECMO duration > 48 hours
  • Obtained written informed consent from the trusted person or family member/relative. Depending on the emergency consent, randomization may take place and consent of the trusted person/relative/family will be obtained as soon as possible. The patient will be asked to give his/her consent for the continuation of the trial when hid/her condition will allow.
  • Affiliation to a social security system (excluding state medical aid)

Exclusion Criteria:

  • Age <18 years
  • Initiation of ECMO for more than 24 hours
  • Surgical (i.e. non percutaneous) cannulation
  • Patient moribund on day of randomization, SAPS II >90
  • Known allergy to chlorhexidine
  • Antibiotic prophylaxis at ECMO cannulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chlorhexidine-impregnated dressings
Device: Chlorhexidine-impregnated dressings
Sterile adhesive transparent dressings impregnated with Chlorhexidine Gluconate gel applied to ECMO cannulae for up to 7 consecutive days for each dressing, in the absence of exudation or bleeding at the point of insertion and until explantation of the ECMO, sometimes requiring dressing changes.
Placebo Comparator: Non impregnated dressings
Device: Non impregnated dressings
Single transparent adhesive dressings not impregnated with Chlorhexidine Gluconate applied to ECMO cannulae for up to 7 consecutive days for each dressing, in the absence of exudation or bleeding at the point of insertion and until explantation of the ECMO, sometimes requiring dressing changes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative incidence per 1000 ECMO days of ECMO cannula-related infection episodes, associated or not with bacteremia/fungemia
Time Frame: From ECMO initiation date (baseline) and up to day 60
From ECMO initiation date (baseline) and up to day 60

Secondary Outcome Measures

Outcome Measure
Time Frame
Colonization of ECMO cannulas at Day 7 and weaning from ECMO
Time Frame: Day 7 to 2 days after ECMO weaning date
Day 7 to 2 days after ECMO weaning date
Number of dressing changes for soiling or detachment
Time Frame: From day 1 to 2 days after ECMO weaning date
From day 1 to 2 days after ECMO weaning date
Number of days alive without antibiotics/fungal agents on ECMO
Time Frame: Between day 1 and Day 60
Between day 1 and Day 60
Total duration of ECMO
Time Frame: Between ECMO initiation date (baseline) and ECMO weaning date
Between ECMO initiation date (baseline) and ECMO weaning date
Number of day in ICU
Time Frame: Between day 1 and Day 60
Between day 1 and Day 60
Overall survival
Time Frame: Day7, Day 30, Day 60
Day7, Day 30, Day 60
Cumulative incidence of ECMO cannula-related bacteremia/fungemia
Time Frame: From ECMO initiation date (baseline) and up to day 60
From ECMO initiation date (baseline) and up to day 60
Cumulative incidence of each cannula infection endpoint in both arms
Time Frame: From ECMO initiation date (baseline) and up to day 60
From ECMO initiation date (baseline) and up to day 60
Incidence of contact dermatitis or skin allergy
Time Frame: From ECMO initiation date (baseline) and up to day 60
From ECMO initiation date (baseline) and up to day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Actual)

June 20, 2025

Study Completion (Actual)

June 20, 2025

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP190190
  • 2020-A02557-32 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe