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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection; Sternal Wound Infection
• Intervention / Treatment: Other: Bacterial cultures taken during surgery.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

• Study Contact: Name: Nadia Sandström, MD; Phone Number: +46 019 602 99 19; Email: nadia.sandstrom@regionorebrolan.se

Study Locations

• Sweden
  • Örebro, Sweden
    • Orebro University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between subgroups	Difference in bacterial growth between subgroups.	Five months

Collaborators and Investigators

• Sponsor: Region Örebro County

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: 274238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No