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Completed

NCT Number: NCT04592328

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

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.

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Sternal Wound Infection Surgical Wound Infection Wound Infection

Sex eligibility

All sexes

Study type

Observational

Primary location

Örebro University hospital

Örebro, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bacterial cultures taken during surgery.

Other

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

Primary outcomes

  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 outcomes

  1. Difference between subgroups

    Time frame: Five months

    Difference in bacterial growth between subgroups.

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Registry information

Official study title

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

Acronym: SWAG

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 19, 2020
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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