Sternal Wound and Aortic Graft (SWAG), an Observational Cohort Study. (SWAG)
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|ClinicalTrials.gov Identifier: NCT04592328|
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
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.
|Condition or disease||Intervention/treatment|
|Surgical Site Infection Sternal Wound Infection||Other: Bacterial cultures taken during surgery.|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||The Presence of Skin Bacteria in the Sternal Wound and Their Possible Ability to Contaminate Implantation Materials During Cardiac Surgery|
|Actual Study Start Date :||October 12, 2020|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||March 1, 2021|
|Patients planned for elective open cardiac surgery||
Other: Bacterial cultures taken during surgery.
Cultures taken from skin, subcutaneous tissue, surigal materials and surgical gloves at incision and after two hours.
- 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
- Difference between subgroups [ Time Frame: Five months ]Difference in bacterial growth between subgroups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04592328
|Contact: Nadia Sandström, MD||019 602 99 19 ext +firstname.lastname@example.org|
|Örebro University hospital||Recruiting|
|Contact: Nadia Sandström, MD 019 602 99 19 ext +46 email@example.com|