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

Study Overview
=================
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.

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

Conditions
-----------------
Surgical Site Infections

Intervention / Treatment
-----------------
* Drug: CHX disinfection
* Drug: PI Disinfection


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cardiothoracic surgery - PI disinfection<br> | Drug: PI Disinfection<br>* 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<br>|
| Active Comparator: Cardiothoracic surgery - CHX disinfection<br> | Drug: CHX disinfection<br>* 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<br>|
| Active Comparator: Abdominal surgery - PI disinfection<br> | Drug: PI Disinfection<br>* 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<br>|
| Active Comparator: Abdominal surgery - CHX disinfection<br> | Drug: CHX disinfection<br>* 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<br>|

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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chlorhexidine in alcoholic solution, PVP iodine in alcoholic solution, preoperative skin antisepsis