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Completed

NCT Number: NCT05750576

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

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

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Key information

Conditions

Cardiogenic Shock Acute Respiratory Distress Syndrome Cardiovascular Diseases Extracorporeal Membrane Oxygenation Complication Heart Diseases Infarction Infections Ischemia Lung Diseases Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Besançon - Hôpital Jean Minjoz, Besançon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine-impregnated dressings

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

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Colonization of ECMO cannulas at Day 7 and weaning from ECMO

    Time frame: Day 7 to 2 days after ECMO weaning date

  2. Number of dressing changes for soiling or detachment

    Time frame: From day 1 to 2 days after ECMO weaning date

  3. Number of days alive without antibiotics/fungal agents on ECMO

    Time frame: Between day 1 and Day 60

  4. Total duration of ECMO

    Time frame: Between ECMO initiation date (baseline) and ECMO weaning date

  5. Number of day in ICU

    Time frame: Between day 1 and Day 60

  6. Overall survival

    Time frame: Day7, Day 30, Day 60

  7. Cumulative incidence of ECMO cannula-related bacteremia/fungemia

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

  8. Cumulative incidence of each cannula infection endpoint in both arms

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

  9. Incidence of contact dermatitis or skin allergy

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: DRESSING-ECMO

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 1, 2023
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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