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

NCT03685604 | Completed Phase 4

• 1 other identifier: 2018-00962; me17Widmer2
• Study Type: interventional
• Target: 3,321
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Surgical Site Infections

Keywords

chlorhexidine in alcoholic solution; PVP iodine in alcoholic solution; preoperative skin antisepsis

Outcome Measures

Primary Outcomes (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.

  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)

• Type of SSI: superficial, deep, organ-space

  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)

  day of surgery

• Change in hemoglobin (g/l)

  day of surgery

• Mortality

  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

  day of surgery

Study Arms (4)

Cardiothoracic surgery - PI disinfection

ACTIVE COMPARATOR

Drug: PI Disinfection

Cardiothoracic surgery - CHX disinfection

ACTIVE COMPARATOR

Drug: CHX disinfection

Abdominal surgery - PI disinfection

ACTIVE COMPARATOR

Drug: PI Disinfection

Abdominal surgery - CHX disinfection

ACTIVE COMPARATOR

Drug: CHX disinfection

Interventions

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

Abdominal surgery - CHX disinfection; Cardiothoracic surgery - CHX disinfection

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

Abdominal surgery - PI disinfection; Cardiothoracic surgery - PI disinfection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss National Science Foundation: collaborator

Study Sites (3)

University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology

Basel, Switzerland

Location

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

Bern, 3010, Switzerland

Location

University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 38884982 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

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

Study Officials

• Andreas Widmer, Prof. Dr. MD

  University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 26, 2018
• Study Start: September 10, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

CH (3)