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NCT Number: NCT03560193

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

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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Key information

Conditions

Cardiac Surgery in Adult Patient Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Clermont-Ferrand, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

2%Chlorhexidine-70%Isopropanol

Drug

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

5%Povidone Iodine- 69%Ethanol

Drug

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

Primary outcomes

  1. Incidence of any re-sternotomy occurring between Day 0 and Day 90 after surgery

    Time frame: 90 days

  2. Incidence of any reoperation on saphen venous/radial artery site occurring between Day 0 and Day 30 after surgery.

    Time frame: 30 days

Secondary outcomes

  1. Incidence of mediastinitis according to CDC criteria occurring by Day 90 after surgery and pathogens involved

    Time frame: 90 days

  2. Incidence of deep incisional SSIs at saphen venous/radial artery site according to CDC criteria occurring by Day 30 after surgery and pathogens involved

    Time frame: 30 days

  3. Incidence of superficial incisional SSIs at sternal or saphen venous/radial artery sites according to CDC criteria occurring by Day 30 after surgery and pathogens involved

    Time frame: 30 days

  4. Incidence of SWI requiring reoperation, occurring by Day 90

    Time frame: 90 days

  5. Incidence of SSIs at saphen venous/radial artery site requiring reoperation, occurring by Day 30

    Time frame: 30 days

  6. Incidence of unexpected need for re-admission to the ICU or re-hospitalisation

    Time frame: 90 days

  7. Number of days in ICU

    Time frame: 90 days

  8. Number of days under mechanical ventilation

    Time frame: 90 days

  9. Number of days in Hospital

    Time frame: 90 days

  10. Number of days in rehabilitation unit

    Time frame: 90 days

  11. Mortality at Day 90 of surgery

    Time frame: 90 days

  12. Incidence of local and systemic side effects possibly linked to antiseptic use

    Time frame: 90 days

  13. Economic analysis including cost-effectiveness of surgical skin antisepsis

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Acronym: CLEAN2

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2018
Registry last updated
Jun 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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