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CLEAN2: Chlorhexidine vs Povidone Iodine in Cardiac Surgery

NCT03560193Phase 4

Key facts

Status: Completed
Start: Sep 2018
Primary completion: May 2022
Countries: 1
Sponsor: CHU de Poitiers
Modality: Small Molecules

Drugs: chlorhexidine + alcohol
Conditions: surgical site infection (SSI)

Overview

Phase 4, randomised, open-label trial of chlorhexidine + alcohol in surgical site infection (SSI) (2 arms), sponsored by CHU de Poitiers. Primary endpoints: Incidence of any re-sternotomy occurring between Day 0 and Day 90 after surgery and Incidence of any reoperation on saphen venous/radial artery site occurring between Day 0 and Day 30 after surgery. Started Sep 2018; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Chlorhexidine Group
2% Chlorhexidine-70% Isopropanol for skin antisepsis
Povidone Iodine Group
5% Povidone Iodine-69% Ethanol for skin antisepsis

Who it enrols

Adult patients undergoing scheduled cardiac surgery (valve, coronary, or combined) or aortic surgery via median sternotomy. Excludes patients with allergies to study drugs, recent cardiac surgery (within 3 months), active infection/inflammation at sternotomy site, or participation in another SSI reduction trial.

Endpoints

Primary

Incidence of any re-sternotomy occurring between Day 0 and Day 90 after surgery90 days
Incidence of any reoperation on saphen venous/radial artery site occurring between Day 0 and Day 30 after surgery30 days

Secondary

Incidence of mediastinitis according to CDC criteria90 days
Incidence of deep incisional SSIs at saphen venous/radial artery site30 days
Incidence of superficial incisional SSIs at sternal or saphen venous/radial artery sites30 days
Mortality at Day 90 of surgery90 days
Number of days in ICU90 days
Number of days in Hospital90 days

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