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Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial

NCT02560155 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2018-02-27

No results posted yet for this study

Summary

Surgical site infections are a major postoperative complication and are mostly due to colonization with endogenous germs, like Staphylococcus aureus, Staphylococcus epidermidis or Propionibacterium acnes. In literature, preoperative decolonization procedures showed a trend in lowering surgical site infection rates, but especially in orthopedic surgery data is controversial and randomized controlled trials are lacking. In the main study, the study investigators aim at performing a controlled prospective randomized interventional trial to measure the impact of preoperative decolonization of nasal Staphylococcus aureus carriers on surgical site infection rates in orthopedic surgery. In an alongside study a controlled prospective randomized interventional trial to measure the impact of preoperative skin decolonization of patients undergoing an orthopedic procedure will be conducted.

Conditions

  • Orthopedic Disorders
  • Surgical Site Infection

Interventions

DRUG

Mupirocin 2% nasal ointement

Mupirocin nasal ointement 2x/d for 5 days preoperatively

DRUG

Chlorhexidine sol 4%

Shower with Chlorhexidine sol 4% once a day for 5 days preoperatively

Sponsors & Collaborators

  • Clinical Trials Unit Bern (CTU)

    collaborator UNKNOWN

  • Lindenhofstiftung

    collaborator UNKNOWN

  • Labormedizinisches Zentrum Dr. Risch

    collaborator INDUSTRY

  • Lindenhofgruppe AG

    lead INDUSTRY

Principal Investigators

  • Jan Brügger, Dr. med. · Lindenhofgruppe AG

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-10-31
Completion
2018-02-28

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 NCT02560155 on ClinicalTrials.gov