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

University Hospital, Basel, Switzerland3,321 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

3,321

Conditions

Surgical Site Infections

Interventions

CHX disinfectionDRUG

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 DisinfectionDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

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, Switzerland

Outcomes

Primary Outcomes

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.

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 Outcomes

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.

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

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).

Time frame: day of surgery

Change in hemoglobin (g/l)

Data from ClinicalTrials.gov

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