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Preoperative Decolonization and Surgical Site Infections in Orthopaedic Surgery - 2 Year Outcome in Prosthetic Surgery

NCT03962907 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1318

Last updated 2020-07-17

No results posted yet for this study

Summary

Surgical site infections in orthopaedic surgery are a major problem. Decolonization has been suggested to reduce infection rates. The study was designed as a prospective, controlled, randomized, single-blinded trial to assess the influence of a decolonization procedure in S. aureus and non - S. aureus carriers. In this trial the 2 - year outcome in the subpopulation of prosthetic elective orthopaedic surgery will be evaluated.

Conditions

  • Staphylococcus Aureus
  • Orthopaedic Surgery
  • Surgical Site Infection
  • Prevention

Interventions

DRUG

Chlorhexidine, Lifo-Scrub sol 4%®, 500ml, B. Braun

5 - day decolonization procedure prior elective surgery. In carriers with Chlorhexidine daily showers and Mupirocin twice a day nasal ointment. In non-carriers Chlorhexidine showers will be used.

DRUG

BACTROBAN® Nasal ong

Mupirocin, BACTROBAN® Nasal ong, 3g, GSK

Sponsors & Collaborators

  • Lindenhofgruppe AG

    lead INDUSTRY

Principal Investigators

  • Jan Brügger, MD · Lindenhofgruppe

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-03-30
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 NCT03962907 on ClinicalTrials.gov