Back to resultsPVP Iodine vs Chlorhexidine in Alcohol for Disinfection of the Surgical Site (PICASSo)
Primary Purpose
Surgical Site Infections
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
CHX disinfection
PI Disinfection
Sponsored by
About this trial
This is an interventional diagnostic trial for Surgical Site Infections focused on measuring chlorhexidine in alcoholic solution, PVP iodine in alcoholic solution, preoperative skin antisepsis
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
Sites / Locations
- University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
- University Hospital of Bern; Division of Infectious Diseases and Hospital Epidemiology
- University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Cardiothoracic surgery - PI disinfection
Cardiothoracic surgery - CHX disinfection
Abdominal surgery - PI disinfection
Abdominal surgery - CHX disinfection
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
Change in hemoglobin (g/l)
Subgroup analysis stratified by laboratory parameters: hemoglobin (g/l)
Mortality
death rate
Timing of antimicrobial prophylaxis
Timing of antimicrobial prophylaxis (antibiotic, dose,time of application)
Duration of surgery
Duration of surgery
Wound contamination -class according to Centers for Disease Control and Prevention(CDC)
Wound contamination -class according to Centers for Disease Control and Prevention(CDC)
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.
Change in creatinine (ymol/l)
Subgroup analysis stratified by laboratory parameters: creatinine (ymol/l)
Change in leukocytes (x10^9/l)
Subgroup analysis stratified by laboratory parameters: leukocytes (x10^9/l)
Change in concentration for C reactive Protein (CRP) (mg/l)
Subgroup analysis stratified by laboratory parameters: CRP (mg/l)
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).
Full Information
NCT ID
NCT03685604
First Posted
September 10, 2018
Last Updated
January 25, 2021
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03685604
Brief Title
PVP Iodine vs Chlorhexidine in Alcohol for Disinfection of the Surgical Site
Acronym
PICASSo
Official Title
Polyvinylpyrrolidone (PVP) Iodine vs Chlorhexidine in Alcohol for Disinfection of the Surgical Site: a Cluster-randomized Multicenter Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infections
Keywords
chlorhexidine in alcoholic solution, PVP iodine in alcoholic solution, preoperative skin antisepsis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3321 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiothoracic surgery - PI disinfection
Arm Type
Active Comparator
Arm Title
Cardiothoracic surgery - CHX disinfection
Arm Type
Active Comparator
Arm Title
Abdominal surgery - PI disinfection
Arm Type
Active Comparator
Arm Title
Abdominal surgery - CHX disinfection
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CHX disinfection
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
PI Disinfection
Intervention Description
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
Primary Outcome Measure Information:
Title
Surgical site infections (SSIs)
Description
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.
Time Frame
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 Measure Information:
Title
Type of SSI: superficial, deep, organ-space
Description
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.
Time Frame
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
Title
Body Mass Index (BMI)
Description
Subgroup analysis stratified by patient factors (i.e. BMI). Weight and height will be combined to report BMI in kg/m^2).
Time Frame
day of surgery
Title
Change in hemoglobin (g/l)
Description
Subgroup analysis stratified by laboratory parameters: hemoglobin (g/l)
Time Frame
day of surgery
Title
Mortality
Description
death rate
Time Frame
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
Title
Timing of antimicrobial prophylaxis
Description
Timing of antimicrobial prophylaxis (antibiotic, dose,time of application)
Time Frame
day of surgery
Title
Duration of surgery
Description
Duration of surgery
Time Frame
time from start to stop of surgical intervention
Title
Wound contamination -class according to Centers for Disease Control and Prevention(CDC)
Description
Wound contamination -class according to Centers for Disease Control and Prevention(CDC)
Time Frame
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
Title
American Society of Anesthesiologists (ASA) -score
Description
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.
Time Frame
day of surgery
Title
Change in creatinine (ymol/l)
Description
Subgroup analysis stratified by laboratory parameters: creatinine (ymol/l)
Time Frame
in- hospital stay (approx. 1 week from surgical intervention)
Title
Change in leukocytes (x10^9/l)
Description
Subgroup analysis stratified by laboratory parameters: leukocytes (x10^9/l)
Time Frame
in- hospital stay (approx. 1 week from surgical intervention)
Title
Change in concentration for C reactive Protein (CRP) (mg/l)
Description
Subgroup analysis stratified by laboratory parameters: CRP (mg/l)
Time Frame
in- hospital stay (approx. 1 week from surgical intervention)
Title
National Nosocomial Infections Surveillance System (NNIS) index
Description
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).
Time Frame
in- hospital stay (approx. 1 week from surgical intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Widmer, Prof. Dr. MD
Organizational Affiliation
University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
City
Basel
Country
Switzerland
Facility Name
University Hospital of Bern; Division of Infectious Diseases and Hospital Epidemiology
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
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PVP Iodine vs Chlorhexidine in Alcohol for Disinfection of the Surgical Site
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