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

Completed

• Conditions: Surgical Site Infection; Sternal Wound Infection
• Interventions: Other: Bacterial cultures taken during surgery.

• Registration Number: NCT04592328
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study Start: 2020-10-12
• Study First Submitted: 2020-10-12
• Study First Submitted QC: 2020-10-12
• Study First Posted: 2020-10-19
• Primary Completion: 2021-09-01
• Study Completion: 2022-12-01
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients planned for elective open cardiac surgery	Bacterial cultures taken during surgery.	-

Primary Outcome Measures

Name	Time	Method
Bacterial growth, C acnes	Five months	Growth of C acnes in cultures taken both from patients and surgical materials used in the primary operation.
Bacterial growth, other	Five months	Growth of bacteria in cultures taken both from patients and surgical materials

Secondary Outcome Measures

Name	Time	Method
Difference between subgroups	Five months	Difference in bacterial growth between subgroups.

Trial Locations

Locations (1)

Örebro University hospital; 🇸🇪 Örebro, Sweden