NCT05750576

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-06-15
• Primary completion: 2025-06-20
• Completion: 2025-06-20
• First posted: 2023-03-01
• Last updated: 2025-11-24

Locations

6 sites across 1 country: France