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NCT Number: NCT03685604

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

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

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Key information

Conditions

Surgical Site Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology, Basel, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHX disinfection

Drug

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

Drug

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 outcomes

  1. Surgical site infections (SSIs)

    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

    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 outcomes

  1. Type of SSI: superficial, deep, organ-space

    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

    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.

  2. Body Mass Index (BMI)

    Time frame: day of surgery

    Subgroup analysis stratified by patient factors (i.e. BMI). Weight and height will be combined to report BMI in kg/m^2).

  3. Change in hemoglobin (g/l)

    Time frame: day of surgery

    Subgroup analysis stratified by laboratory parameters: hemoglobin (g/l)

  4. Mortality

    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

    death rate

  5. Timing of antimicrobial prophylaxis

    Time frame: day of surgery

    Timing of antimicrobial prophylaxis (antibiotic, dose,time of application)

  6. Duration of surgery

    Time frame: time from start to stop of surgical intervention

    Duration of surgery

  7. 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

    Wound contamination -class according to Centers for Disease Control and Prevention(CDC)

  8. American Society of Anesthesiologists (ASA) -score

    Time frame: day of surgery

    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.

  9. Change in creatinine (ymol/l)

    Time frame: in- hospital stay (approx. 1 week from surgical intervention)

    Subgroup analysis stratified by laboratory parameters: creatinine (ymol/l)

  10. Change in leukocytes (x10^9/l)

    Time frame: in- hospital stay (approx. 1 week from surgical intervention)

    Subgroup analysis stratified by laboratory parameters: leukocytes (x10^9/l)

  11. Change in concentration for C reactive Protein (CRP) (mg/l)

    Time frame: in- hospital stay (approx. 1 week from surgical intervention)

    Subgroup analysis stratified by laboratory parameters: CRP (mg/l)

  12. National Nosocomial Infections Surveillance System (NNIS) index

    Time frame: in- hospital stay (approx. 1 week from surgical intervention)

    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).

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

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

Acronym: PICASSo

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2018
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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