Skip to main content
OpenTrials
Completed

NCT Number: NCT03922191

Post-Surgical Mediastinitis Within the CHU Brugmann Hospital

Mediastinitis is an infectious complication that can occur after cardiac surgery. The incidence varies between 1 and 3% depending on the type of procedure and the patient's condition. The mortality of this severe postoperative complication rises from 10 to 35%, which makes it dreadful.

The major risk factors reported are obesity, diabetes, and immunosuppressive therapy. There are other less important ones: age, coronary bypass grafting (especially if using the two internal mammary arteries), nosocomial pneumonia, dialysis, prolonged mechanical ventilation, long operative asepsis, undrained retro-sternally hematoma, prolonged pre-operative hospitalization...).

Prevention is very important. The principle of asepsis must absolutely be respected. The use of prophylactic antibiotic therapy is recommended.

The most commonly encountered organisms are Staphylococcus aureus, coagulase-negative Staphylococci and gram-negative bacilli.

There are several treatment modalities that vary between centers and may be different depending on the surgical team's experience and the depth or extent of the infection. The common principles of these treatments are: antibiotic therapy and surgical debridement (the timing of which may vary). The timing and modalities of wound closure are subject to variations: immediate sternal closure with placement of multiple or delayed drains. Muscle flaps or large omentum transplant may be necessary if tissue loss is too important.

The investigators propose to review their experience in the treatment of cardiac post-surgery mediastinitis at Brugmann University Hospital in the last 20 years in both adult and pediatric patients.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • post-cardiac surgery mediastinitis
  • patients of the CHU Brugmann (adults) and HUDERF (pediatric) Hospitals

Exclusion criteria

  • none

Treatment and study plan

Data extraction from medical files

Other

Data extraction from medical files

Primary outcomes

  1. Duration of the hospitalization

    Time frame: 20 years

    Duration of the hospitalization

  2. Mortality at six months

    Time frame: 6 months

    Mortality rate six months after mediastinitis diagnosis

  3. Percentage of recurrence

    Time frame: 20 years

    Percentage of recurrence of mediastinitis

  4. Percentage of re-hospitalization

    Time frame: 20 years

    Percentage of re-hospitalizations caused by mediastinitis

  5. Duration of the antibiotic treatment

    Time frame: 20 years

    Duration of the antibiotic treatment for mediastinitis

  6. Presence of superinfection

    Time frame: 20 years

    Presence of superinfection

Secondary outcomes

  1. Date of birth

    Time frame: 20 years

    Demographic data : Date of birth.

  2. Sex

    Time frame: 20 years

    Demographic data : sex.

  3. Risk factors

    Time frame: 20 years

    Demographic data : presence of risk factors (obesity, diabetes...).

  4. Surgical intervention

    Time frame: 20 years

    Name of the surgical intervention that caused the mediastinitis

  5. Germ identification

    Time frame: 20 years

    Name of the germ causing the mediastinitis

  6. Type of treatment

    Time frame: 20 years

    Name of the antibiotics used to treat the mediastinitis

Sponsors and collaborators

Lead sponsor

Pierre Wauthy

Other

Registry information

Official study title

Post-Surgical Mediastinitis: Retrospective Study of Cases Treated Within the CHU Brugmann Hospital

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2019
Registry last updated
Jul 16, 2019

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.

Published trials that share one or more normalized conditions with this study.