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

Surgical Site Infections Clinical Trial

— PICASSo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03685604
• Other study ID #: 2018-00962; me17Widmer2
• Status: Completed
• Phase: Phase 4
• Start date: September 10, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3321
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Site Infections
• Surgical Wound Infection

Intervention

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
• 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

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology	Basel
Switzerland	University Hospital of Bern; Division of Infectious Diseases and Hospital Epidemiology	Bern
Switzerland	University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change in hemoglobin (g/l)	Subgroup analysis stratified by laboratory parameters: hemoglobin (g/l)	day of surgery
Secondary	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
Secondary	Timing of antimicrobial prophylaxis	Timing of antimicrobial prophylaxis (antibiotic, dose,time of application)	day of surgery
Secondary	Duration of surgery	Duration of surgery	time from start to stop of surgical intervention
Secondary	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
Secondary	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
Secondary	Change in creatinine (ymol/l)	Subgroup analysis stratified by laboratory parameters: creatinine (ymol/l)	in- hospital stay (approx. 1 week from surgical intervention)
Secondary	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)
Secondary	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)
Secondary	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)