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
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
270
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.
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.
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
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
Colonization of ECMO cannulas at Day 7 and weaning from ECMO
Time frame: 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
Number of days alive without antibiotics/fungal agents on ECMO
Time frame: Between day 1 and Day 60
Total duration of ECMO
Time frame: Between ECMO initiation date (baseline) and ECMO weaning date
Number of day in ICU
Time frame: Between day 1 and Day 60
Overall survival
Time frame: 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
Cumulative incidence of each cannula infection endpoint in both arms
Time frame: 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
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