Wound Contamination During Orthopaedic Surgery

Hip Fractures Clinical Trial

— Clean Care  

Official title:

Assessment of Relationships Between Airborne Microorganisms and Wound Contamination During Orthopaedic Surgery - a Trial Within the Clean Care Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04676841
• Other study ID #: 2019-02180
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: November 2022

Study information

• Verified date: November 2020
• Source: Vastra Gotaland Region
• Contact: Annette Erichsen Andersson
• Phone: +46 73 725 04 58
• Email: annette.erichsen.andersson[@]gu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Hip Fractures
• Implant Infection
• Infection
• Musculoskeletal Diseases
• Orthopedic Disorder
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Device:
• Conventional ventilation + instrumental tables with integrated laminar airflow
Surgical instruments protected from contamination by local laminar airflow
• Conventional ventilation + standard instrumental tables
Control
• Laminar airflow ventilation + standard instrumental tables
Control

Locations

Country	Name	City	State
Sweden	Department of Ortopedics, Sahlgrenska University Hospital	Mölndal

Sponsors (7)

Lead Sponsor	Collaborator
Vastra Gotaland Region	CRC Medical AB, Getinge AB, Göteborg University, Halmstad University, RISE - Research Institutes of Sweden, Toul Meditech AB

Country where clinical trial is conducted

Sweden, 

Outcome

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