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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine Group | Experimental |
| |
| Povidone Iodine Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2%Chlorhexidine-70%Isopropanol | Drug | 2% Chlorhexidine-70% isopropanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of any re-sternotomy occurring between Day 0 and Day 90 after surgery | 90 days | |
| Incidence of any reoperation on saphen venous/radial artery site occurring between Day 0 and Day 30 after surgery. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of mediastinitis according to CDC criteria occurring by Day 90 after surgery and pathogens involved | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Clermont-Ferrand | Clermont-Ferrand | 63100 | France | |||
| University Hospital of Nantes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39531051 | Derived | 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. | |
| 31213447 |
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| 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 |
|
| 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 | 30 days |
| Incidence of SWI requiring reoperation, occurring by Day 90 | 90 days |
| Incidence of SSIs at saphen venous/radial artery site requiring reoperation, occurring by Day 30 | 30 days |
| Incidence of unexpected need for re-admission to the ICU or re-hospitalisation | 90 days |
| Number of days in ICU | 90 days |
| Number of days under mechanical ventilation | 90 days |
| Number of days in Hospital | 90 days |
| Number of days in rehabilitation unit | 90 days |
| Mortality at Day 90 of surgery | 90 days |
| Incidence of local and systemic side effects possibly linked to antiseptic use | 90 days |
| Economic analysis including cost-effectiveness of surgical skin antisepsis | 90 days |
| Nantes |
| 44000 |
| France |
| La Pitié Salpétrière Hospital | Paris | 75013 | France |
| Institut Mutualiste Montsouris | Paris | 75014 | France |
| University Hospital of Poitiers | Poitiers | 86021 | France |
| University Hospital of Rennes | Rennes | France |
| CHRU de Strasbourg | Strasbourg | 67091 | France |
| CHU de Toulouse | Toulouse | 31400 | France |
| Derived |
| Boisson 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. |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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