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

Polyvinylpyrrolidone (PVP) Iodine vs Chlorhexidine in Alcohol for Disinfection of the Surgical Site: a Cluster-randomized Multicenter Trial

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

Study Overview

• Status: Completed
• Conditions: Surgical Site Infections
• Intervention / Treatment: Drug: PI Disinfection; Drug: CHX disinfection

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.

• Study Type: Interventional
• Enrollment (Actual): 3321
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland
    • University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
  • Bern, Switzerland, 3010
    • University Hospital of Bern; Division of Infectious Diseases and Hospital Epidemiology
  • Zurich, Switzerland, 8091
    • University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cardiothoracic surgery - PI disinfection	Drug: PI Disinfection; PI (Braunoderm® from B.Braun or Betaseptic® from Mundipharma) is applied prior to surgery on the patient's skin with the use of swabs. The product is applied three times. The cumulative residence time is a minimum of 3 minutes. The application is performed according to standard procedures of the participating centers and according to manufacturer's recommendations
Active Comparator: Cardiothoracic surgery - CHX disinfection	Drug: CHX disinfection; CHX (Softasept® Chlorhexidine solution 2% coloured, from B. Braun Medical AG) is applied three times on the patient's skin with the use of swabs. The cumulative residence time is a minimum of 3 minutes. The application is performed according to standard procedures of the participating centers and according to manufacturer's recommendations
Active Comparator: Abdominal surgery - PI disinfection	Drug: PI Disinfection; PI (Braunoderm® from B.Braun or Betaseptic® from Mundipharma) is applied prior to surgery on the patient's skin with the use of swabs. The product is applied three times. The cumulative residence time is a minimum of 3 minutes. The application is performed according to standard procedures of the participating centers and according to manufacturer's recommendations
Active Comparator: Abdominal surgery - CHX disinfection	Drug: CHX disinfection; CHX (Softasept® Chlorhexidine solution 2% coloured, from B. Braun Medical AG) is applied three times on the patient's skin with the use of swabs. The cumulative residence time is a minimum of 3 minutes. The application is performed according to standard procedures of the participating centers and according to manufacturer's recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infections (SSIs)	Comparison of SSI rates between the two groups using standard chi-square test. Presence of SSIs for abdominal and cardiac surgeries as defined by Swiss society of hospital epidemiologists (Swissnoso) according to National Healthcare Safety Network (NHSN) criteria. Analysis will be performed using the final SSI rate (30 days for abdominal, 30 days/1 year for cardiac surgery) and according to the different types of infections. Infection ratio will be calculated as crude ratio as well as adapted to the National Nosocomial Infections Surveillance System (NNIS) score. The method of aggregation for the combined SSI rate for both types of surgery together will be a weighted average based on the proportion of SSIs from each surgery type. The measure includes no scale.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of SSI: superficial, deep, organ-space	Type of SSI: superficial, deep, organ-space; DEFINITIONS OF SSI: For surveillance classification purposes, SSIs are divided into incisional SSIs and organ/space SSIs. Incisional SSIs are further classified into those involving only the skin and subcutaneous tissue (called superficial incisional SSIs) and those involving deep soft tissues of the incision (called deep incisional SSIs (e.g., fascial and muscle layers)). Organ/space SSIs involve any part of the anatomy (e.g., organs or spaces), other than the incision, opened or manipulated during the operative procedure.	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
Body Mass Index (BMI)	Subgroup analysis stratified by patient factors (i.e. BMI). Weight and height will be combined to report BMI in kg/m^2).	day of surgery
Change in hemoglobin (g/l)	Subgroup analysis stratified by laboratory parameters: hemoglobin (g/l)	day of surgery
Mortality	death rate	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
Timing of antimicrobial prophylaxis	Timing of antimicrobial prophylaxis (antibiotic, dose,time of application)	day of surgery
Duration of surgery	Duration of surgery	time from start to stop of surgical intervention
Wound contamination -class according to Centers for Disease Control and Prevention(CDC)	Wound contamination -class according to Centers for Disease Control and Prevention(CDC)	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
American Society of Anesthesiologists (ASA) -score	ASA physical status classification system is a system for assessing the fitness of patients before surgery. These are: Healthy person.; Mild systemic disease.; Severe systemic disease.; Severe systemic disease that is a constant threat to life.; A moribund person who is not expected to survive without the operation.; A declared brain-dead person whose organs are being removed for donor purposes.	day of surgery
Change in creatinine (ymol/l)	Subgroup analysis stratified by laboratory parameters: creatinine (ymol/l)	in- hospital stay (approx. 1 week from surgical intervention)
Change in leukocytes (x10^9/l)	Subgroup analysis stratified by laboratory parameters: leukocytes (x10^9/l)	in- hospital stay (approx. 1 week from surgical intervention)
Change in concentration for C reactive Protein (CRP) (mg/l)	Subgroup analysis stratified by laboratory parameters: CRP (mg/l)	in- hospital stay (approx. 1 week from surgical intervention)
National Nosocomial Infections Surveillance System (NNIS) index	NNIS index takes into account 3 risk factors, and each is awarded 1 point: contaminated or dirty-infected surgical wound, American Society of Anesthesiology (ASA) score greater than 2 and surgery duration longer than T (where T is defined as the 75th percentile of the average time for a surgical procedure).	in- hospital stay (approx. 1 week from surgical intervention)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Swiss National Science Foundation
• Investigators: Principal Investigator: Andreas Widmer, Prof. Dr. MD, University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: chlorhexidine in alcoholic solution; PVP iodine in alcoholic solution; preoperative skin antisepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection
• Other Study ID Numbers: 2018-00962; me17Widmer2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No