Wound Contamination During Orthopaedic Surgery (Clean Care)

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

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.

Study Overview

• Status: Unknown
• Conditions: Hip Fractures; Surgical Site Infection; Orthopedic Disorder; Implant Infection
• Intervention / Treatment: Device: Conventional ventilation + instrumental tables with integrated laminar airflow; Device: Conventional ventilation + standard instrumental tables; Device: Laminar airflow ventilation + standard instrumental tables

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Annette Erichsen Andersson; Phone Number: +46 73 725 04 58; Email: annette.erichsen.andersson@gu.se
• Study Contact Backup: Name: Henrik Malchau; Phone Number: +46 70 820 76 51; Email: henrik.malchau@vgregion.se

Study Locations

• Sweden
  • Mölndal, Sweden, 43180
    • Recruiting
    • Department of Ortopedics, Sahlgrenska University Hospital
    • Contact: Annette Erichsen Andersson; Phone Number: +46 73 725 04 58

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hip fracture patients operated with hemiarthroplasty

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hemiarthroplasty; Hip fracture patients operated with hemiarthroplasty	Device: Conventional ventilation + instrumental tables with integrated laminar airflow; Surgical instruments protected from contamination by local laminar airflow; Device: Conventional ventilation + standard instrumental tables; Control; Device: Laminar airflow ventilation + standard instrumental tables; Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Collaborators: Göteborg University; Halmstad University; RISE - Research Institutes of Sweden; CRC Medical AB; Getinge AB; Toul Meditech AB
• Investigators: Principal Investigator: Henrik Malchau, Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Infection control; SSI; Operating room; LAF; UDF; Wound contamination; Airborne contamination
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Fractures, Bone; Wounds and Injuries; Leg Injuries; Disease Attributes; Femoral Fractures; Hip Injuries; Wound Infection; Infections; Communicable Diseases; Hip Fractures; Musculoskeletal Diseases; Surgical Wound Infection
• Other Study ID Numbers: 2019-02180

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No