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Wound Contamination During Orthopaedic Surgery (Clean Care)

V

Vastra Gotaland Region

Status

Unknown

Conditions

Orthopedic Disorder
Hip Fractures
Implant Infection
Surgical Site Infection

Treatments

Device: Laminar airflow ventilation + standard instrumental tables
Device: Conventional ventilation + standard instrumental tables
Device: Conventional ventilation + instrumental tables with integrated laminar airflow

Study type

Observational

Funder types

Other

Identifiers

NCT04676841
2019-02180

Details and patient eligibility

About

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.

Full description

The scientific literature on the relationship between airborne bacteria and wound contamination during different conditions is scares. A study from 1982 (Whyet et al.), demonstrated that the most important and consistent source of contamination of the wound during clean surgery (in this case hip implant surgery) was via air. The study concluded that approximately one third of bacteria in the wound were caused by direct air contamination whereas the remaining number of bacteria were transferred to the wound by indirect routes such as via contaminated instruments.

The present study includes patients undergoing hemiarthroplastic surgery due to hip fracture.

During the surgery active air sampling, for microbial analysis, will be done within 30 cm from the wound.

Passive sampling of instrument tables, to measure number of depositing bacteria on the surface during the procedure, will be performed by placing sterile filters on the table surfaces before initiating the surgical procedure and collecting them at the end.

Skin and wound sampling will be performed with sterile flocked nylon swabs. The method for skin and wound sampling was decided based on a literature review and discussions with the department of Clinical microbiology at Sahlgrenska University hospital. Both aerobe and anaerobe bacteria will be analyzed.

The wound will be measured and number of personnel, door openings and clothing, at each procedure will be recorded.

Patients included in the study will be interviewed after 6 weeks and 1 year, to evaluate incidence rate of SSI.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing hip fracture surgery treated with hemiarthroplasty implant and that are subsequently cared for at participating ortho-geriatric unit

Exclusion criteria

  • Patients that will not give their informed consent.
  • Patient that, at the time of surgery, have an infection in any part of the body, hospital or community acquired.
  • Patients receiving fracture fixation with pins only

Trial design

100 participants in 1 patient group

Hemiarthroplasty
Description:
Hip fracture patients operated with hemiarthroplasty
Treatment:
Device: Conventional ventilation + instrumental tables with integrated laminar airflow
Device: Conventional ventilation + standard instrumental tables
Device: Laminar airflow ventilation + standard instrumental tables

Trial contacts and locations

1

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Central trial contact

Annette Erichsen Andersson; Henrik Malchau

Data sourced from clinicaltrials.gov

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