Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04592328
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Region Örebro County

Brief 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.


Condition or disease Intervention/treatment
Surgical Site Infection Sternal Wound Infection Other: Bacterial cultures taken during surgery.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. Bacterial growth, other [ Time Frame: Five months ]
    Growth of bacteria in cultures taken both from patients and surgical materials


Secondary Outcome Measures :
  1. Difference between subgroups [ Time Frame: Five months ]
    Difference in bacterial growth between subgroups.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Nadia Sandström, MD 019 602 99 19 ext +46 nadia.sandstrom@regionorebrolan.se

Locations
Layout table for location information
Sweden
Örebro University hospital Recruiting
Örebro, Sweden
Contact: Nadia Sandström, MD    019 602 99 19 ext +46    nadia.sandstrom@regionorebrolan.se   
Sponsors and Collaborators
Region Örebro County
Layout table for additonal information
Responsible Party: Region Örebro County
ClinicalTrials.gov Identifier: NCT04592328    
Other Study ID Numbers: 274238
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes