Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2019-09-01
2022-11-30
Brief Summary
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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
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hemiarthroplasty
Hip fracture patients operated with hemiarthroplasty
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Research Institutes of Sweden
OTHER
Göteborg University
OTHER
CRC Medical AB
UNKNOWN
Getinge AB
UNKNOWN
Toul Meditech AB
UNKNOWN
Halmstad University
OTHER
Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Principal Investigators
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Henrik Malchau
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital
Locations
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Department of Ortopedics, Sahlgrenska University Hospital
Mölndal, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Annette Erichsen Andersson
Role: primary
Other Identifiers
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2019-02180
Identifier Type: -
Identifier Source: org_study_id