Wound Contamination During Orthopaedic Surgery
- Conditions
- Orthopedic DisorderSurgical Site InfectionHip FracturesImplant Infection
- Interventions
- Device: Conventional ventilation + instrumental tables with integrated laminar airflowDevice: Conventional ventilation + standard instrumental tablesDevice: Laminar airflow ventilation + standard instrumental tables
- Registration Number
- NCT04676841
- Lead Sponsor
- Vastra Gotaland Region
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Patients undergoing hip fracture surgery treated with hemiarthroplasty implant and that are subsequently cared for at participating ortho-geriatric unit
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Hemiarthroplasty Conventional ventilation + standard instrumental tables Hip fracture patients operated with hemiarthroplasty Hemiarthroplasty Laminar airflow ventilation + standard instrumental tables Hip fracture patients operated with hemiarthroplasty Hemiarthroplasty Conventional ventilation + instrumental tables with integrated laminar airflow Hip fracture patients operated with hemiarthroplasty
- Primary Outcome Measures
Name Time Method 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 2019-2021 Active airsampling within 30cm from the surgical wound will be performed during surgery and number of collected aerobe and anaerobe bacteria analyzed.
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 2019-2021 The entire wound is swabed before closure, aerobe and anaerobe bacteria analyzed.
- Secondary Outcome Measures
Name Time Method Bacterial species in air collected during surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables 2019-2022 The bacterial species in collected samples are identified with MALDI-TOF
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 The bacterial species in collected samples are identified with MALDI-TOF
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 Swab sample is taken of the skin directly prior to incission, aerobe and anaerobe bacteria analyzed.
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 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.
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 Patients are contacted 6 weeks and 1 year after surgery and incidense and severrensess of infection recorded
Trial Locations
- Locations (1)
Department of Ortopedics, Sahlgrenska University Hospital
🇸🇪Mölndal, Sweden