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Wound Contamination During Orthopaedic Surgery

NCT04676841 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-12-21

No results posted yet for this study

Summary

In the present study we will compare bacteriological findings and the incidence of SSI in relation to laminar airflow (LAF) ventilated ORs, conventional (also called displacement or mixed) ventilated ORs and conventional ventilated ORs with the addition of tables equipped with units providing a local LAF over the surgical instruments.

The hypothesis is that there exist a correlation between number and types of airborne bacteria and bacteria in the surgical wound and on surgical instruments at the time of wound closure.

Conditions

  • Surgical Site Infection
  • Hip Fractures
  • Orthopedic Disorder
  • Implant Infection

Interventions

DEVICE

Conventional ventilation + instrumental tables with integrated laminar airflow

Surgical instruments protected from contamination by local laminar airflow

DEVICE

Conventional ventilation + standard instrumental tables

Control

DEVICE

Laminar airflow ventilation + standard instrumental tables

Control

Sponsors & Collaborators

  • Research Institutes of Sweden

    collaborator OTHER

  • Göteborg University

    collaborator OTHER

  • CRC Medical AB

    collaborator UNKNOWN

  • Getinge AB

    collaborator UNKNOWN

  • Toul Meditech AB

    collaborator UNKNOWN

  • Halmstad University

    collaborator OTHER

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Henrik Malchau · Sahlgrenska University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-11-30
Completion
2022-11-30

Countries

  • Sweden

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 NCT04676841 on ClinicalTrials.gov