Hip Fractures Clinical Trial
— Clean CareOfficial title:
Assessment of Relationships Between Airborne Microorganisms and Wound Contamination During Orthopaedic Surgery - a Trial Within the Clean Care Project
NCT number | NCT04676841 |
Other study ID # | 2019-02180 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2019 |
Est. completion date | November 2022 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | November 2022 |
Est. primary completion date | November 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Ortopedics, Sahlgrenska University Hospital | Mölndal |
Lead Sponsor | Collaborator |
---|---|
Vastra Gotaland Region | CRC Medical AB, Getinge AB, Göteborg University, Halmstad University, RISE - Research Institutes of Sweden, Toul Meditech AB |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | Swab sample is taken of the skin directly prior to incission, aerobe and anaerobe bacteria analyzed. | 2019-2022 | |
Secondary | CFU/dm2 on the instrument tables during surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables | Passive sampling of bacteria falling down on the instrument tables during the duration of each surgical procedure will be analyzed. Aerobe and anaerobe bacteria analyzed. | 2019-2022 | |
Secondary | Bacterial species in air collected during surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables | The bacterial species in collected samples are identified with MALDI-TOF | 2019-2022 | |
Secondary | Bacterial species in wound samples collected during surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables | The bacterial species in collected samples are identified with MALDI-TOF | 2019-2022 | |
Secondary | Number and sort of SSI in patients operated in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables | Patients are contacted 6 weeks and 1 year after surgery and incidense and severrensess of infection recorded | 2019-2022 |
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