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

Surgical Site Infection Clinical Trial

— SWAG  

Official title:

The Presence of Skin Bacteria in the Sternal Wound and Their Possible Ability to Contaminate Implantation Materials During Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04592328
• Other study ID #: 274238
• Status: Completed
• Start date: October 12, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2020
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Sternal Wound Infection
• Surgical Site Infection
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

Other:
• Bacterial cultures taken during surgery.
Cultures taken from skin, subcutaneous tissue, surigal materials and surgical gloves at incision and after two hours.

Locations

Country	Name	City	State
Sweden	Örebro University hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial growth, C acnes	Growth of C acnes in cultures taken both from patients and surgical materials used in the primary operation.	Five months
Primary	Bacterial growth, other	Growth of bacteria in cultures taken both from patients and surgical materials	Five months
Secondary	Difference between subgroups	Difference in bacterial growth between subgroups.	Five months