Introduction
Surgical-site infection (SSI) is the second most frequent cause of
healthcare-associated infection worldwide and is associated with
increased morbidity, mortality and healthcare costs. Cardiac surgery is
clean surgery with low incidence of SSI, ranging from 2% to 5%, but with
potentially severe consequences.
Perioperative skin antisepsis with an alcohol-based antiseptic
solution is recommended to prevent SSI, but the superiority of
chlorhexidine (CHG)–alcohol over povidone iodine (PVI)–alcohol, the two
most common alcohol-based antiseptic solutions used worldwide, is
controversial. We aim to evaluate whether 2% CHG–70% isopropanol is more
effective than 5% PVI–69% ethanol in reducing the incidence of
reoperation after cardiac surgery.
Methods and analysis
The CLEAN 2 study is a multicentre, open-label, randomised,
controlled clinical trial of 4100 patients undergoing cardiac surgery.
Patients will be randomised in 1:1 ratio to receive either 2% CHG–70%
isopropanol or 5% PVI–69% ethanol for perioperative skin preparation.
The primary endpoint is the proportion of patients undergoing any
re-sternotomy between day 0 and day 90 after initial surgery and/or any
reoperation on saphenous vein/radial artery surgical site between day 0
and day 30 after initial surgery. Data will be analysed on the
intention-to-treat principle.
Ethics and dissemination
This protocol has been approved by an independent ethics committee
and will be carried out according to the principles of the Declaration
of Helsinki and the Good Clinical Practice guidelines. The results of
this study will be disseminated through presentation at scientific
conferences and publication in peer-reviewed journals.
Trial registration number
EudraCT 2017-005169-33 and NCT03560193.
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