Wound Contamination During Orthopaedic Surgery

NCT04676841 | Unknown

• 1 other identifier: 2019-02180
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

LAF; UDF; SSI; Wound contamination; Infection control; Airborne contamination; Operating room

Outcome Measures

Primary Outcomes (2)

• Live bacterial Count (colony forming units, CFU) per meter3 air during surgery; in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables

  Active airsampling within 30cm from the surgical wound will be performed during surgery and number of collected aerobe and anaerobe bacteria analyzed.

  2019-2021

• Number of CFU in the surgical wound before closure; after surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables

  The entire wound is swabed before closure, aerobe and anaerobe bacteria analyzed.

  2019-2021

Secondary Outcomes (5)

• CFU/dm2 on the patients skin Before directly prior to incission, before surgery in surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables

  2019-2022

• CFU/dm2 on the instrument tables during surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables

  2019-2022

• Bacterial species in air collected during surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables

  2019-2022

• Bacterial species in wound samples collected during surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables

  2019-2022

• Number and sort of SSI in patients operated in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables

  2019-2022

Study Arms (1)

Hemiarthroplasty

Hip fracture patients operated with hemiarthroplasty

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

Interventions

Conventional ventilation + instrumental tables with integrated laminar airflow DEVICE

Surgical instruments protected from contamination by local laminar airflow

Hemiarthroplasty

Conventional ventilation + standard instrumental tables DEVICE

Control

Hemiarthroplasty

Laminar airflow ventilation + standard instrumental tables DEVICE

Control

Hemiarthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hip fracture patients operated with hemiarthroplasty

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Research Institutes of Sweden: collaborator
• Göteborg University: collaborator
• CRC Medical AB: collaborator
• Getinge AB: collaborator
• Toul Meditech AB: collaborator
• Halmstad University: collaborator

Study Sites (1)

Department of Ortopedics, Sahlgrenska University Hospital

Mölndal, 43180, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Swab samples for microbial analysis. Samples taken from skin before surgery and from surgical wound before closure.

MeSH Terms

Conditions

Surgical Wound Infection; Hip Fractures; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Henrik Malchau

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annette Erichsen Andersson

CONTACT

+46 73 725 04 58; annette.erichsen.andersson@gu.se

Henrik Malchau

CONTACT

+46 70 820 76 51; henrik.malchau@vgregion.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 21, 2020
• Study Start: September 1, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2022
• Last Updated: December 21, 2020

Record last verified: 2020-11

Locations

SE (1)