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

NCT ID: NCT05750576

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2025-06-20

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

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.

Conditions

Cardiogenic Shock; Extracorporeal Membrane Oxygenation Complication; Acute Respiratory Distress Syndrome; Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Chlorhexidine-impregnated dressings

Group Type: EXPERIMENTAL

Chlorhexidine-impregnated dressings

Intervention Type: DEVICE

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.

Non impregnated dressings

Group Type: PLACEBO_COMPARATOR

Non impregnated dressings

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Besançon - Hôpital Jean Minjoz

Besançon, , France

CH Sud Francilien

Corbeil-Essonnes, , France

Hôpital Henri-Mondor

Créteil, , France

CHRU Nancy - Hôpitaux de Brabois

Nancy, , France

Hôpital Pitié Salpêtrière

Paris, , France

Hôpital Foch

Suresnes, , France

Countries

France

Other Identifiers

2020-A02557-32

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190190

Identifier Type: -

Identifier Source: org_study_id