Clinical trial NCT04676841: Wound Contamination During Orthopaedic Surgery
Official title: Assessment of Relationships Between Airborne Microorganisms and Wound Contamination During Orthopaedic Surgery - a Trial Within the Clean Care Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgical Site Infection
Hip Fractures
Orthopedic Disorder
Implant Infection
Keywords: LAF
UDF
SSI
Wound contamination
Infection control
Airborne contamination
Operating room
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Research Institutes of Sweden
name: Göteborg University
name: CRC Medical AB
name: Getinge AB
name: Toul Meditech AB
name: Halmstad University
First posted: 2020-12-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hip fracture patients operated with hemiarthroplasty

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 2019-2021
measure: 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
timeFrame: 2019-2021
Secondary outcomes:
measure: 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
timeFrame: 2019-2022
measure: CFU/dm2 on the instrument tables during surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables
timeFrame: 2019-2022
measure: Bacterial species in air collected during surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables
timeFrame: 2019-2022
measure: Bacterial species in wound samples collected during surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables
timeFrame: 2019-2022
measure: Number and sort of SSI in patients operated in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables
timeFrame: 2019-2022
Other outcomes:
Locations:
city: Mölndal
country: Sweden
facility: Department of Ortopedics, Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Henrik Malchau
role: PRINCIPAL_INVESTIGATOR
References: