Cardiac Surgery in Adult PatientPhase 4CLEAN2NCT03560193
Randomized Trial of 2% Chlorhexidine-70% Isopropanol vs 5% Povidone Iodine-69% Ethanol for Skin Antisepsis in Reducing Surgical-site Infection After Cardiac Surgery
A Phase 4 study testing 2%Chlorhexidine-70%Isopropanol and 5%Povidone Iodine- 69%Ethanol in people with Cardiac Surgery in Adult Patient, run by Poitiers University Hospital at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery in Adult Patient
- What is being tested?
- 2%Chlorhexidine-70%Isopropanol and 5%Povidone Iodine- 69%Ethanol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,316 participants
- Where
- 8 sitesFrance
- Study dates
- 10 Sep 2018to 25 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
University Hospital of Clermont-Ferrand
Clermont-Ferrand, 63100
University Hospital of Nantes
Nantes, 44000
La Pitié Salpétrière Hospital
Paris, 75013
Institut Mutualiste Montsouris
Paris, 75014
University Hospital of Poitiers
Poitiers, 86021
University Hospital of Rennes
Rennes
CHRU de Strasbourg
Strasbourg, 67091
CHU de Toulouse
Toulouse, 31400
About this study
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
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.
Read more
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.
- Conditions
- Cardiac Surgery in Adult Patient
- Being tested
- 2%Chlorhexidine-70%Isopropanol, 5%Povidone Iodine- 69%Ethanol
- Keywords
- Skin antisepsis, Chlorhexidine, Povidone Iodine, Surgical site infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2%Chlorhexidine-70%IsopropanolDrug
2% Chlorhexidine-70% isopropanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes
5%Povidone Iodine- 69%EthanolDrug
5%Povidone Iodine- 69%Ethanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine Group | Experimental | Not described Receives: Drug: 2%Chlorhexidine-70%Isopropanol |
| Povidone Iodine Group | Active comparator | Not described Receives: Drug: 5%Povidone Iodine- 69%Ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any re-sternotomy occurring between Day 0 and Day 90 after surgery
Measured: 90 days
Incidence of any reoperation on saphen venous/radial artery site occurring between Day 0 and Day 30 after surgery.
Measured: 30 days
Secondary outcomes (13)
Incidence of mediastinitis according to CDC criteria occurring by Day 90 after surgery and pathogens involved
Measured: 90 days
Incidence of deep incisional SSIs at saphen venous/radial artery site according to CDC criteria occurring by Day 30 after surgery and pathogens involved
Measured: 30 days
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
Measured: 30 days
Incidence of SWI requiring reoperation, occurring by Day 90
Measured: 90 days
Incidence of SSIs at saphen venous/radial artery site requiring reoperation, occurring by Day 30
Measured: 30 days
Incidence of unexpected need for re-admission to the ICU or re-hospitalisation
Measured: 90 days
Number of days in ICU
Measured: 90 days
Number of days under mechanical ventilation
Measured: 90 days
Number of days in Hospital
Measured: 90 days
Number of days in rehabilitation unit
Measured: 90 days
Mortality at Day 90 of surgery
Measured: 90 days
Incidence of local and systemic side effects possibly linked to antiseptic use
Measured: 90 days
Economic analysis including cost-effectiveness of surgical skin antisepsis
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start10 Sep 2018
- Primary completion25 May 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgery in Adult PatientStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560193
- Sponsor's protocol ID
- CLEAN2
- Acronym
- CLEAN2
- Status last verified
- Jun 2022
- First submitted
- 24 May 2018
- Last updated
- 13 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boisson M, Allain G, Roussel JC, d'Ostrevy N, Burbassi S, Demondion P, Mertes PM, Labaste F, Kerforne T, Rozec B, Eljezi V, Zannis K, Leprince P, Oulehri W, Minville V, Seguin S, Loiodice A, Ruckly S, Lucet JC, Timsit JF, Mimoz O; CLEAN 2 Study Group. Chlorhexidine-alcohol compared with povidone-iodine-alcohol skin antisepsis protocols in major cardiac surgery: a randomized clinical trial. Intensive Care Med. 2024 Dec;50(12):2114-2124. doi: 10.1007/s00134-024-07693-0. Epub 2024 Nov 12.
PubMed 39531051Boisson M, Corbi P, Kerforne T, Camilleri L, Debauchez M, Demondion P, Eljezi V, Flecher E, Lepelletier D, Leprince P, Nesseler N, Nizou JY, Roussel JC, Rozec B, Ruckly S, Lucet JC, Timsit JF, Mimoz O. Multicentre, open-label, randomised, controlled clinical trial comparing 2% chlorhexidine-70% isopropanol and 5% povidone iodine-69% ethanol for skin antisepsis in reducing surgical-site infection after cardiac surgery: the CLEAN 2 study protocol. BMJ Open. 2019 Jun 17;9(6):e026929. doi: 10.1136/bmjopen-2018-026929.
PubMed 31213447
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03560193
- Acronym / sponsor ID
- CLEAN2 / CLEAN2
- Conditions
- Cardiac Surgery in Adult Patient
- Keywords
- Skin antisepsis, Chlorhexidine, Povidone Iodine, Surgical site infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,316 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine Group | Experimental | Drug: 2%Chlorhexidine-70%Isopropanol |
| Povidone Iodine Group | Active comparator | Drug: 5%Povidone Iodine- 69%Ethanol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2%Chlorhexidine-70%Isopropanol2% Chlorhexidine-70% isopropanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes | Drug | Chlorhexidine Group |
| 5%Povidone Iodine- 69%Ethanol5%Povidone Iodine- 69%Ethanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes | Drug | Povidone Iodine Group |
Primary outcome
Incidence of any re-sternotomy occurring between Day 0 and Day 90 after surgery
Time frame: 90 days
Incidence of any reoperation on saphen venous/radial artery site occurring between Day 0 and Day 30 after surgery.
Time frame: 30 days
13 secondary outcomes
Incidence of mediastinitis according to CDC criteria occurring by Day 90 after surgery and pathogens involved
Time frame: 90 days
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
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
Incidence of SWI requiring reoperation, occurring by Day 90
Time frame: 90 days
Incidence of SSIs at saphen venous/radial artery site requiring reoperation, occurring by Day 30
Time frame: 30 days
Incidence of unexpected need for re-admission to the ICU or re-hospitalisation
Time frame: 90 days
Number of days in ICU
Time frame: 90 days
Number of days under mechanical ventilation
Time frame: 90 days
Number of days in Hospital
Time frame: 90 days
Number of days in rehabilitation unit
Time frame: 90 days
Mortality at Day 90 of surgery
Time frame: 90 days
Incidence of local and systemic side effects possibly linked to antiseptic use
Time frame: 90 days
Economic analysis including cost-effectiveness of surgical skin antisepsis
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Derived from this study: PubMed 39531051Boisson M, Allain G, Roussel JC, d'Ostrevy N, Burbassi S, Demondion P, Mertes PM, Labaste F, Kerforne T, Rozec B, Eljezi V, Zannis K, Leprince P, Oulehri W, Minville V, Seguin S, Loiodice A, Ruckly S, Lucet JC, Timsit JF, Mimoz O; CLEAN 2 Study Group. Chlorhexidine-alcohol compared with povidone-iodine-alcohol skin antisepsis protocols in major cardiac surgery: a randomized clinical trial. Intensive Care Med. 2024 Dec;50(12):2114-2124. doi: 10.1007/s00134-024-07693-0. Epub 2024 Nov 12.
- Derived from this study: PubMed 31213447Boisson M, Corbi P, Kerforne T, Camilleri L, Debauchez M, Demondion P, Eljezi V, Flecher E, Lepelletier D, Leprince P, Nesseler N, Nizou JY, Roussel JC, Rozec B, Ruckly S, Lucet JC, Timsit JF, Mimoz O. Multicentre, open-label, randomised, controlled clinical trial comparing 2% chlorhexidine-70% isopropanol and 5% povidone iodine-69% ethanol for skin antisepsis in reducing surgical-site infection after cardiac surgery: the CLEAN 2 study protocol. BMJ Open. 2019 Jun 17;9(6):e026929. doi: 10.1136/bmjopen-2018-026929.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2%Chlorhexidine-70%Isopropanol and 5%Povidone Iodine- 69%Ethanol in people with Cardiac Surgery in Adult Patient, run by Poitiers University Hospital at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of any re-sternotomy occurring between Day 0 and Day 90 after surgery (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03560193, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.