NCT03560193: CLEAN2

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

Completed Phase 4 Last updated 13 June 2022

What this trial tests

Phase 4 trial testing 2%Chlorhexidine-70%Isopropanol in Cardiac Surgery in Adult Patient in 3,316 participants. Completed in 25 May 2022.

Timeline

10 September 2018

Primary endpoint
25 May 2022

25 May 2022

Quick facts

Lead sponsor	Poitiers University Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	3,316
Start date	10 September 2018
Primary completion	25 May 2022
Estimated completion	25 May 2022
Sites	8 locations across France

Drugs / interventions tested

• 2%Chlorhexidine-70%Isopropanol — full drug profile →
• 5%Povidone Iodine- 69%Ethanol — full drug profile →

Conditions studied

• Cardiac Surgery in Adult Patient — all drugs for Cardiac Surgery in Adult Patient →

Sponsor

Poitiers University Hospital

Who can join

18 and older, any sex, with Cardiac Surgery in Adult Patient. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Boisson M, Corbi P, Kerforne T, Camilleri L, et al · · 2019 · cited 6× · PMID 31213447 · DOI 10.1136/bmjopen-2018-026929
2. Chlorhexidine-alcohol compared with povidone-iodine-alcohol skin antisepsis protocols in major cardiac surgery: a randomized clinical trial.
   Boisson M, Allain G, Roussel JC, d'Ostrevy N, et al · · 2024 · cited 4× · PMID 39531051 · DOI 10.1007/s00134-024-07693-0