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CompletedNCT04592328SWAGUpdated Mar 29, 2023

Sternal Wound and Aortic Graft (SWAG), an Observational Cohort Study.

An observational study in Surgical Site Infection and Sternal Wound Infection, sponsored by Region Örebro County. Completed at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2023-03-29.

Sponsored by Region Örebro County · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Sex
All
01

Study 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.

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.

02

Conditions studied

03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 50 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Region Örebro County is the lead sponsor of 123 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Consecutive patients undergoing cardiac surgery at the Cardiothoracic and Vascular surgery Department at the University Hospital in Örebro.

Inclusion criteria

  • Open cardiac surgery; coronary artery bypass grafting, valve replacement/repair or a combination of these.

Exclusion criteria

Exclusion Criteria:

  • Skin conditions such as eczema, psoriasis.
  • Revision surgery
  • Aortic surgery
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients planned for elective open cardiac surgery

    Other: Bacterial cultures taken during surgery.

Interventions

  • OtherBacterial cultures taken during surgery.

    Cultures taken from skin, subcutaneous tissue, surigal materials and surgical gloves at incision and after two hours.

06

What researchers measure

Primary outcomes

  1. Bacterial growth, C acnes

    Growth of C acnes in cultures taken both from patients and surgical materials used in the primary operation.

    Time frame: Five months

  2. Bacterial growth, other

    Growth of bacteria in cultures taken both from patients and surgical materials

    Time frame: Five months

Secondary outcomes

  1. Difference between subgroups

    Difference in bacterial growth between subgroups.

    Time frame: Five months

07

Study locations

1 site
  • Örebro University hospital
    Örebro, Sweden
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04592328
Lead sponsor
Region Örebro County
Responsible party
Sponsor
First posted
Oct 19, 2020
Start date
Oct 12, 2020
Primary completion
Sep 1, 2021
Completion
Dec 1, 2022
Last update
Mar 29, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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