Clinical trial NCT03685604: PVP Iodine vs Chlorhexidine in Alcohol for Disinfection of the Surgical Site
Official title: Polyvinylpyrrolidone (PVP) Iodine vs Chlorhexidine in Alcohol for Disinfection of the Surgical Site: a Cluster-randomized Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Site Infections
Keywords: chlorhexidine in alcoholic solution
PVP iodine in alcoholic solution
preoperative skin antisepsis
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2018-09-26
Enrollment: 3321
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention will be conducted as an open-label cluster-randomized cross-over multicenter trial with an allocation ratio of 1:1.

The departments of surgery of the 3 study sites will be randomized center-wise in clusters by month to use CHX or PI. The products will be switched over according to the computer-generated randomization list.
Primary purpose: DIAGNOSTIC

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical site infections (SSIs)
timeFrame: occurrence of surgical site infections is evaluated at three time points: at time of dismissal from the hospital (approx. 1 week after surgical intervention); 30 days after abdominal and cardiac surgery; 1 year for cardiac surgery
Secondary outcomes:
measure: Type of SSI: superficial, deep, organ-space
timeFrame: three time points: at time of dismissal from the hospital (approx. 1 week after surgical intervention); 30 days after abdominal and cardiac surgery; 1 year for cardiac surgery
measure: Body Mass Index (BMI)
timeFrame: day of surgery
measure: Change in hemoglobin (g/l)
timeFrame: day of surgery
measure: Mortality
timeFrame: in-hospital (approx. 1 week from surgical intervention) and 30 day for abdominal surgery; in-hospital (approx. 1 week from surgical intervention), 30 day and 365 day for cardiac surgery
measure: Timing of antimicrobial prophylaxis
timeFrame: day of surgery
measure: Duration of surgery
timeFrame: time from start to stop of surgical intervention
measure: Wound contamination -class according to Centers for Disease Control and Prevention(CDC)
timeFrame: three time points: at time of dismissal from the hospital (approx. 1 week after surgical intervention); 30 days after abdominal and cardiac surgery; 1 year for cardiac surgery
measure: American Society of Anesthesiologists (ASA) -score
timeFrame: day of surgery
measure: Change in creatinine (ymol/l)
timeFrame: in- hospital stay (approx. 1 week from surgical intervention)
measure: Change in leukocytes (x10^9/l)
timeFrame: in- hospital stay (approx. 1 week from surgical intervention)
measure: Change in concentration for C reactive Protein (CRP) (mg/l)
timeFrame: in- hospital stay (approx. 1 week from surgical intervention)
measure: National Nosocomial Infections Surveillance System (NNIS) index
timeFrame: in- hospital stay (approx. 1 week from surgical intervention)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
city: Bern
country: Switzerland
facility: University Hospital of Bern; Division of Infectious Diseases and Hospital Epidemiology
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology
Study officials:
affiliation: University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
name: Andreas Widmer, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
References: