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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05750576
Collaborator
(none)
270
2
34

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Chlorhexidine-impregnated dressings
  • Device: Non impregnated dressings
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
270 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Impact of ECMO Cannula Chlorhexidine-impregnated Dressings to Decrease Extracorporeal Membrane Oxygenation-cannula Related Infection Rate
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chlorhexidine-impregnated dressings

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.

Placebo Comparator: Non impregnated dressings

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.

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. Colonization of ECMO cannulas at Day 7 and weaning from ECMO [Day 7 to 2 days after ECMO weaning date]

  2. Number of dressing changes for soiling or detachment [From day 1 to 2 days after ECMO weaning date]

  3. Number of days alive without antibiotics/fungal agents on ECMO [Between day 1 and Day 60]

  4. Total duration of ECMO [Between ECMO initiation date (baseline) and ECMO weaning date]

  5. Number of day in ICU [Between day 1 and Day 60]

  6. Overall survival [Day7, Day 30, Day 60]

  7. Cumulative incidence of ECMO cannula-related bacteremia/fungemia [From ECMO initiation date (baseline) and up to day 60]

  8. Cumulative incidence of each cannula infection endpoint in both arms [From ECMO initiation date (baseline) and up to day 60]

  9. Incidence of contact dermatitis or skin allergy [From ECMO initiation date (baseline) and up to day 60]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT05750576
Other Study ID Numbers:
  • APHP190190
  • 2020-A02557-32
First Posted:
Mar 1, 2023
Last Update Posted:
Mar 1, 2023
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 1, 2023