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Randomized Trial of 2% Chlorhexidine-70% Isopropanol vs 5% Povidone Iodine-69% Ethanol for Skin Antisepsis in Reducing Surgical-site Infection After Cardiac Surgery (CLEAN2)

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ClinicalTrials.gov Identifier: NCT03560193
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cardiac Surgery in Adult Patient Drug: 2%Chlorhexidine-70%Isopropanol Drug: 5%Povidone Iodine- 69%Ethanol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: Chlorhexidine Group Drug: 2%Chlorhexidine-70%Isopropanol
2% Chlorhexidine-70% isopropanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes

Active Comparator: Povidone Iodine Group 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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560193


Contacts
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Contact: Olivier MIMOZ, Professor +33549444600 olivier.mimoz@chu-poitiers.fr
Contact: Matthieu BOISSON, Hospital Practitioner +33549444635 matthieu.boisson@chu-poitiers.fr

Locations
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France
University Hospital of Bordeaux Not yet recruiting
Bordeaux, France, 33000
Contact: Louis Labrousse, Professor    +33557656969    louis.labrousse@chu-bordeaux.fr   
Contact: Alexandre Ouattara, Professor    +330557656866    alexandre.ouattara@chu-bordeaux.fr   
University Hospital of Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63100
Contact: Lionel Camilleri, Professor    +33473751576    lcamilleri@chu-clermontferrand.fr   
University Hospital of Nantes Not yet recruiting
Nantes, France, 44000
Contact: Jean-Christian Roussel, Professor    +33240165084    jeanchristian.roussel@chu-nantes.fr   
Contact: Bertrand Rozec, Professor    +33240165304    bertrand.rozec@chu-nantes.fr   
La pitié Salpétrière Hospital Recruiting
Paris, France, 75013
Contact: Pierre Demondion, Hospital Practitioner    +33142160000    pierre.demondion@aphp.fr   
Institut Mutualiste Montsouris Recruiting
Paris, France, 75014
Contact: Jacques-Yves Nizou, Hospital Practitioner    +33156616069    JacquesYves.NIZOU@imm.fr   
Contact: Mathieu Debauchez, Hospital Practitioner    +33156616556    Mathieu.DEBAUCHEZ@imm.fr   
University Hospital of Poitiers Recruiting
Poitiers, France, 86021
Contact: Olivier MIMOZ, Professor    +33549444600    olivier.mimoz@chu-poitiers.fr   
Contact: Matthieu BOISSON, Hospital Practitioner    +33549444635    matthieu.boisson@chu-poitiers.fr   
University Hospital of Rennes Not yet recruiting
Rennes, France
Contact: Nicolas Nesseler, Hospital Practitioner    +33299284321    nicolas.nesseler@chu-rennes.fr   
Sponsors and Collaborators
Poitiers University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03560193     History of Changes
Other Study ID Numbers: CLEAN2
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Poitiers University Hospital:
Skin antisepsis
Chlorhexidine
Povidone Iodine
Surgical site infection

Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Infection
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Iodine
Cadexomer iodine
Ethanol
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Central Nervous System Depressants
Plasma Substitutes
Blood Substitutes