Randomized Trial of 2% Chlorhexidine-70% Isopropanol vs 5% Povidone Iodine-69% Ethanol for Skin Antisepsis in Reducing Surgical-site Infection After Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-10

Study Completion Date

2022-05-25

Brief Summary

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Despite completion of more than 9 million procedures each year in France, the best antiseptic solution to be used for preparing the skin to reduce risk of surgical site infection (SSI) remains unknown. 2% Chlorhexidine gluconate (CHG)-alcohol is superior to Povidone Iodine (PVI)-alcohol for short term vascular catheter care (Mimoz O, Lancet 2015; Pages J, Intensive Care Med 2016), but studies comparing both antiseptic solutions for clean-contaminated surgical procedures led to conflicting results.

The present study will be the first large scale multicenter randomized controlled trial adequately powered to compare efficacy and safety of CHG-alcohol over PVI-alcohol in reducing SSI after clean surgery.

A clean surgery was chosen because pathogens involved in SSI mostly originate from skin. Therefore, optimisation of skin disinfection before surgery has the potential to reduce the incidence of SSI. Cardiac surgery was chosen because SSI may be severe, diagnosis of SSI is easy to monitor and to define and infections arise earlier than other frequent clean surgeries using implants such as orthopaedic or vascular surgery.

The incidence of reoperation for any purpose will be used as the main objective because there are easy to track and define and are less susceptible to interpretation in an open trial than superficial SSI. According to CDC criteria, patients will be monitored up to Day 90 because mediastinitis after cardiac surgery may occur after the usual 30-day SSI surveillance period.

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Detailed Description

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Conditions

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Cardiac Surgery in Adult Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Chlorhexidine Group

Group Type EXPERIMENTAL

2%Chlorhexidine-70%Isopropanol

Intervention Type DRUG

2% Chlorhexidine-70% isopropanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes

Povidone Iodine Group

Group Type ACTIVE_COMPARATOR

5%Povidone Iodine- 69%Ethanol

Intervention Type DRUG

5%Povidone Iodine- 69%Ethanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes

Interventions

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2%Chlorhexidine-70%Isopropanol

2% Chlorhexidine-70% isopropanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes

Intervention Type DRUG

5%Povidone Iodine- 69%Ethanol

5%Povidone Iodine- 69%Ethanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients (age ≥ 18 years)
* Undergoing any (scheduled) surgery of the heart (valve, coronary or combined surgery) or of the aorta via a median sternotomy
* Having given their informed consent

Exclusion Criteria

* Patients with known allergies to CHG, PVI, isopropanol or ethanol
* Surgery for heart transplantation
* Any signs of inflammation or sternal instability at the site of sternotomy or operation for infection (SWI or endocarditis)
* Patients with history of cardiac surgery within 3 months preceding enrolment
* Participation to another clinical trial aimed at reducing SSI
* Patients already enrolled in this study
* Pregnant or breastfeeding women
* Women at age to procreate and not using effective contraception
* Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No