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

NCT03685604 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3321

Last updated 2021-01-26

No results posted yet for this study

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

Interventions

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

DRUG

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

Sponsors & Collaborators

  • Swiss National Science Foundation

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Andreas Widmer, Prof. Dr. MD · University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-10
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03685604 on ClinicalTrials.gov