NCT04676841

Wound Contamination During Orthopaedic Surgery

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Site Infection
• Hip Fractures
• Orthopedic Disorder
• Implant Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-11-01
• Completion: 2022-11-01
• First posted: 2020-12-21
• Last updated: 2020-12-21

Locations

1 site across 1 country: Sweden