NCT05750576

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

6 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

January 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

January 19, 2023

Last Update Submit

November 20, 2025

Conditions

Cardiogenic ShockExtracorporeal Membrane Oxygenation ComplicationAcute Respiratory Distress SyndromeInfections

Keywords

ECMOCardiogenic ShockARDSInfection

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence per 1000 ECMO days of ECMO cannula-related infection episodes, associated or not with bacteremia/fungemia

    From ECMO initiation date (baseline) and up to day 60

Secondary Outcomes (9)

  • Colonization of ECMO cannulas at Day 7 and weaning from ECMO

    Day 7 to 2 days after ECMO weaning date

  • Number of dressing changes for soiling or detachment

    From day 1 to 2 days after ECMO weaning date

  • Number of days alive without antibiotics/fungal agents on ECMO

    Between day 1 and Day 60

  • Total duration of ECMO

    Between ECMO initiation date (baseline) and ECMO weaning date

  • Number of day in ICU

    Between day 1 and Day 60

  • +4 more secondary outcomes

Study Arms (2)

Chlorhexidine-impregnated dressings

EXPERIMENTAL
Device: Chlorhexidine-impregnated dressings

Non impregnated dressings

PLACEBO COMPARATOR
Device: Non impregnated dressings

Interventions

Chlorhexidine-impregnated dressingsDEVICE

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.

Chlorhexidine-impregnated dressings
Non impregnated dressingsDEVICE

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.

Non impregnated dressings

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU Besançon - Hôpital Jean Minjoz

Besançon, 25000, France

Location

CH Sud Francilien

Corbeil-Essonnes, 91100, France

Location

Hôpital Henri-Mondor

Créteil, 94000, France

Location

CHRU Nancy - Hôpitaux de Brabois

Nancy, 54500, France

Location

Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Shock, CardiogenicRespiratory Distress SyndromeInfections

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShockLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2023

First Posted

March 1, 2023

Study Start

June 15, 2023

Primary Completion

June 20, 2025

Study Completion

June 20, 2025

Last Updated

November 24, 2025

Record last verified: 2025-11

Locations

FR(6)