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Surgical Site InfectionsPhase 4PICASSoNCT03685604

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

A Phase 4 study testing CHX disinfection and PI Disinfection in people with Surgical Site Infections, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgical Site Infections
What is being tested?
CHX disinfection and PI Disinfection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,321 participants
Where
3 sitesSwitzerland
Study dates
10 Sep 2018to 30 Jun 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Switzerland3 sites

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

    Basel

  • University Hospital of Bern; Division of Infectious Diseases and Hospital Epidemiology

    Bern, 3010

  • University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology

    Zurich, 8091

Other trials in Switzerland

About this study

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

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

Read the 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.

Being tested
CHX disinfection, PI Disinfection
Keywords
chlorhexidine in alcoholic solution, PVP iodine in alcoholic solution, preoperative skin antisepsis
Medical subject headings
Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT03685604
Study groupRoleWhat they receive
Cardiothoracic surgery - PI disinfectionActive comparatorNot described
Receives: Drug: PI Disinfection
Cardiothoracic surgery - CHX disinfectionActive comparatorNot described
Receives: Drug: CHX disinfection
Abdominal surgery - PI disinfectionActive comparatorNot described
Receives: Drug: PI Disinfection
Abdominal surgery - CHX disinfectionActive comparatorNot described
Receives: Drug: CHX disinfection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 (12)

  1. 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.

    Measured: 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

  2. 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).

    Measured: day of surgery

  3. Change in hemoglobin (g/l)

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

    Measured: day of surgery

  4. Mortality

    death rate

    Measured: 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

  5. Timing of antimicrobial prophylaxis

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

    Measured: day of surgery

  6. Duration of surgery

    Duration of surgery

    Measured: time from start to stop of surgical intervention

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

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

    Measured: 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

  8. American Society of Anesthesiologists (ASA) -score

    ASA physical status classification system is a system for assessing the fitness of patients before surgery. These are:

    1. Healthy person.
    2. Mild systemic disease.
    3. Severe systemic disease.
    4. Severe systemic disease that is a constant threat to life.
    5. A moribund person who is not expected to survive without the operation.
    6. A declared brain-dead person whose organs are being removed for donor purposes.

    Measured: day of surgery

  9. Change in creatinine (ymol/l)

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

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

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

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

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

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

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

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

  12. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2018
  2. Study start10 Sep 2018
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
3,321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03685604
Sponsor's protocol ID
2018-00962; me17Widmer2
Other IDs
2018
Acronym
PICASSo
Status last verified
Jan 2021
First submitted
10 Sep 2018
Last updated
26 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Widmer AF, Atkinson A, Kuster SP, Wolfensberger A, Klimke S, Sommerstein R, Eckstein FS, Schoenhoff F, Beldi G, Gutschow CA, Marschall J, Schweiger A, Jent P. Povidone Iodine vs Chlorhexidine Gluconate in Alcohol for Preoperative Skin Antisepsis: A Randomized Clinical Trial. JAMA. 2024 Aug 20;332(7):541-549. doi: 10.1001/jama.2024.8531.

    PubMed 38884982

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CHX disinfection and PI Disinfection in people with Surgical Site Infections, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03685604, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.

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