Surgical Site InfectionClean CareNCT04676841
Wound Contamination During Orthopaedic Surgery
An observational study of Surgical Site Infection and Hip Fractures, run by Vastra Gotaland Region at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection, Hip Fractures, Orthopedic Disorder
- What is being tested?
- Conventional ventilation + instrumental tables with integrated laminar airflow, Conventional ventilation + standard instrumental tables and Laminar airflow ventilation + standard instrumental tables
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2019to Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hip fracture patients operated with hemiarthroplasty
Who may be able to join
- Patients undergoing hip fracture surgery treated with hemiarthroplasty implant and that are subsequently cared for at participating ortho-geriatric unit
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Ortopedics, Sahlgrenska University Hospital
Mölndal, 43180
Annette Erichsen Andersson, +46 73 725 04 58
About this study
Official title: 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.
Read the 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.
- Being tested
- Conventional ventilation + instrumental tables with integrated laminar airflow, Conventional ventilation + standard instrumental tables, Laminar airflow ventilation + standard instrumental tables
- Keywords
- LAF, UDF, SSI, Wound contamination, Infection control, Airborne contamination, Operating room
- Medical subject headings
- Surgical Wound Infection, Hip Fractures, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional ventilation + instrumental tables with integrated laminar airflowDevice
Surgical instruments protected from contamination by local laminar airflow
Conventional ventilation + standard instrumental tablesDevice
Control
Laminar airflow ventilation + standard instrumental tablesDevice
Control
| Study group | Role | What they receive |
|---|---|---|
| Hemiarthroplasty | Hip fracture patients operated with hemiarthroplasty Receives: Device: Conventional ventilation + instrumental tables with integrated laminar airflow; Device: Conventional ventilation + standard instrumental tables; Device: Laminar airflow ventilation + standard instrumental tables |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2019-2021
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 2019-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Sep 2019
- Primary completionNov 2021 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Research Institutes of Sweden, Göteborg University, CRC Medical AB, Getinge AB, Toul Meditech AB, Halmstad University
- Responsible party
- Sponsor
- Investigators
- Henrik Malchau, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676841
- Sponsor's protocol ID
- 2019-02180
- Other IDs
- 2019
- Acronym
- Clean Care
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Relationships Between Airborne Microorganisms and Wound Contamination During Orthopaedic Surgery - a Trial Within the Clean Care Project
- ClinicalTrials.gov ID
- NCT04676841
- Acronym / sponsor ID
- Clean Care / 2019-02180
- Keywords
- LAF, UDF, SSI, Wound contamination, Infection control, Airborne contamination, Operating room
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Research Institutes of Sweden, Göteborg University, CRC Medical AB, Getinge AB, Toul Meditech AB, Halmstad University
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemiarthroplasty | – | Device: Conventional ventilation + instrumental tables with integrated laminar airflow, Device: Conventional ventilation + standard instrumental tables, Device: Laminar airflow ventilation + standard instrumental tablesHip fracture patients operated with hemiarthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hip fracture patients operated with hemiarthroplasty
Key inclusion criteria (1 listed)
- Patients undergoing hip fracture surgery treated with hemiarthroplasty implant and that are subsequently cared for at participating ortho-geriatric unit
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional ventilation + instrumental tables with integrated laminar airflowSurgical instruments protected from contamination by local laminar airflow | Device | Hemiarthroplasty |
| Conventional ventilation + standard instrumental tablesControl | Device | Hemiarthroplasty |
| Laminar airflow ventilation + standard instrumental tablesControl | Device | Hemiarthroplasty |
Primary outcome
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
Time frame: 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
Time frame: 2019-2021
The entire wound is swabed before closure, aerobe and anaerobe bacteria analyzed.
5 secondary outcomes
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
Time frame: 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
Time frame: 2019-2022
Bacterial species in air collected during surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables
Time frame: 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
Time frame: 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
Time frame: 2019-2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Malchau principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection and Hip Fractures, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annette Erichsen Andersson (+46 73 725 04 58, annette.erichsen.andersson@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2019-2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.