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

NCT04592328 | Completed

• 1 other identifier: 274238
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection; Sternal Wound Infection

Outcome Measures

Primary Outcomes (2)

• Bacterial growth, C acnes

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

  Five months

• Bacterial growth, other

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

  Five months

Secondary Outcomes (1)

• Difference between subgroups

  Five months

Study Arms (1)

Patients planned for elective open cardiac surgery

Other: Bacterial cultures taken during surgery.

Interventions

Bacterial cultures taken during surgery. OTHER

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

Patients planned for elective open cardiac surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Örebro University hospital

Örebro, Sweden

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 19, 2020
• Study Start: October 12, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2022
• Last Updated: March 29, 2023

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)