PVP Iodine vs Chlorhexidine in Alcohol for Disinfection of the Surgical Site (PICASSo)

University Hospital Basel

Status and phase: Completed; Phase 4

Conditions: Surgical Site Infections

Treatments: Drug: CHX disinfection; Drug: PI Disinfection

Study type: Interventional

Funder types: Other

Identifiers

NCT03685604

2018-00962 me17Widmer2;

Details and patient eligibility

About

Prospective cluster-randomized multicenter cross-over trial to prove non-inferiority of PI compared to CHX in preoperative skin antisepsis

Full description

Surgical site infections (SSIs) are the most common nosocomial infections in surgical patients causing significant increases in morbidity, mortality, and health care costs. As they are usually caused by components of the normal skin flora, disinfection of the surgical site with an antiseptic skin preparation is standard practice prior to any surgical intervention. The most commonly used disinfectants are either chlorhexidine in alcoholic solution (CHX) or PVP iodine in alcoholic solution (PI) This prospective cluster-randomized multicenter cross-over trial is to prove non-inferiority of PI compared to CHX in preoperative skin antisepsis in abdominal and cardiothoracic surgery in regard of SSIs.

Enrollment: 3,321 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• undergoing cardiac or certain types of abdominal surgery (colorectal surgery, cholecystectomy, herniotomy, appendectomy and bariatric surgery) which are routinely followed up by the study Centers during the study period

Exclusion criteria

• contraindication to the use of either one of the compounds ( CHX: intolerance to any of the compounds of the preparation, application on cornea, wounds or mucosal Membrane. PI: hyperthyroid disease, intolerance to any of the compounds, iodine allergy, 2 weeks prior to radio- iodine treatment, Dermatitis herpetiformis Duhring, application on cornea, wounds or mucosal membranes)
• Emergency surgical Intervention
• Patients refusing General consent for use of personal data

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,321 participants in 4 patient groups

Cardiothoracic surgery - PI disinfection

Active Comparator group

Treatment:

Drug: PI Disinfection

Cardiothoracic surgery - CHX disinfection

Active Comparator group

Treatment:

Drug: CHX disinfection

Abdominal surgery - PI disinfection

Active Comparator group

Treatment:

Drug: PI Disinfection

Abdominal surgery - CHX disinfection

Active Comparator group

Treatment:

Drug: CHX disinfection