Surgical Site InfectionSWAGNCT04592328
Sternal Wound and Aortic Graft (SWAG), an Observational Cohort Study.
An observational study of Surgical Site Infection and Sternal Wound Infection, run by Region Örebro County at 1 site in Sweden.
Trial summary
The aim of this study is to systematically explore the perioperative presence of P acnes in all layers of sternal wound incision as well as contamination of graft material and prosthetic valves during primary operation. Secondly, to compare if different regimes of antibiotics affects the bacterial growth. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Site Infection, Sternal Wound Infection
- What is being tested?
- Bacterial cultures taken during surgery.
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 12 Oct 2020to 1 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients undergoing cardiac surgery at the Cardiothoracic and Vascular surgery Department at the University Hospital in Örebro.
Who may be able to join
- Open cardiac surgery; coronary artery bypass grafting, valve replacement/repair or a combination of these.
Who cannot join
- Skin conditions such as eczema, psoriasis.
- Revision surgery
- Aortic surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Presence of Skin Bacteria in the Sternal Wound and Their Possible Ability to Contaminate Implantation Materials During Cardiac Surgery
The aim of this study is to systematically explore the perioperative presence of P acnes in all layers of sternal wound incision as well as contamination of graft material and prosthetic valves during primary operation. Secondly, to compare if different regimes of antibiotics affects the bacterial growth.
Cultures will be taken from the skin, subcutaneous, and from the implanted valve prostheses with a rayon swab.Graft and Felt material will, after being pressed subcutaneous for 15 sec, placed into prepared sterile bottles containing broth for aerobe and anaerobe cultures. Surgical gloves will be cultured.
- Conditions
- Surgical Site Infection, Sternal Wound Infection
- Being tested
- Bacterial cultures taken during surgery.
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacterial cultures taken during surgery.Other
Cultures taken from skin, subcutaneous tissue, surigal materials and surgical gloves at incision and after two hours.
| Study group | Role | What they receive |
|---|---|---|
| Patients planned for elective open cardiac surgery | Not described Receives: Other: Bacterial cultures taken during surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial growth, C acnes
Growth of C acnes in cultures taken both from patients and surgical materials used in the primary operation.
Measured: Five months
Bacterial growth, other
Growth of bacteria in cultures taken both from patients and surgical materials
Measured: Five months
Secondary outcomes (1)
Difference between subgroups
Difference in bacterial growth between subgroups.
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start12 Oct 2020
- Primary completion1 Sep 2021
- Study completion1 Dec 2022
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592328
- Sponsor's protocol ID
- 274238
- Acronym
- SWAG
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2020
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Presence of Skin Bacteria in the Sternal Wound and Their Possible Ability to Contaminate Implantation Materials During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04592328
- Acronym / sponsor ID
- SWAG / 274238
- Conditions
- Surgical Site Infection, Sternal Wound Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 19 Oct 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.
The aim of this study is to systematically explore the perioperative presence of P acnes in all layers of sternal wound incision as well as contamination of graft material and prosthetic valves during primary operation. Secondly, to compare if different regimes of antibiotics affects the bacterial growth.
Cultures will be taken from the skin, subcutaneous, and from the implanted valve prostheses with a rayon swab.Graft and Felt material will, after being pressed subcutaneous for 15 sec, placed into prepared sterile bottles containing broth for aerobe and anaerobe cultures. Surgical gloves will be cultured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients planned for elective open cardiac surgery | – | Other: Bacterial cultures taken during surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients undergoing cardiac surgery at the Cardiothoracic and Vascular surgery Department at the University Hospital in Örebro.
Key inclusion criteria (1 listed)
- Open cardiac surgery; coronary artery bypass grafting, valve replacement/repair or a combination of these.
Key exclusion criteria (3 listed)
- Skin conditions such as eczema, psoriasis.
- Revision surgery
- Aortic surgery
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 |
|---|---|---|
| Bacterial cultures taken during surgery.Cultures taken from skin, subcutaneous tissue, surigal materials and surgical gloves at incision and after two hours. | Other | Patients planned for elective open cardiac surgery |
Primary outcome
Bacterial growth, C acnes
Time frame: Five months
Growth of C acnes in cultures taken both from patients and surgical materials used in the primary operation.
Bacterial growth, other
Time frame: Five months
Growth of bacteria in cultures taken both from patients and surgical materials
1 secondary outcome
Difference between subgroups
Time frame: Five months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sternal Wound Infection, run by Region Örebro County 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: finished, as of the sponsor's last update on 29 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial growth, C acnes (time frame: Five months). 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 29 Mar 2023.