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Post-Surgical Mediastinitis Within the CHU Brugmann Hospital

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03922191
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Information provided by (Responsible Party):
Pierre Wauthy, Brugmann University Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment
Mediastinitis Other: Data extraction from medical files

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Study Type : Observational
Estimated Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Post-Surgical Mediastinitis: Retrospective Study of Cases Treated Within the CHU Brugmann Hospital
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Pediatric population
Infants diagnosed with cardiac post-surgery mediastinitis within the HUDERF Hospital within the last 20 years.
Other: Data extraction from medical files
Data extraction from medical files

Adult population
Adults diagnosed with cardiac post-surgery mediastinitis within the CHU Brugmann Hospital within the last 20 years.
Other: Data extraction from medical files
Data extraction from medical files

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of the CHU Brugmann (adults) and HUDERF (pediatric) Hospitals, treated for post-cardiac surgery mediastinitis.

Inclusion Criteria:

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

Exclusion Criteria:

- none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03922191

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Contact: Laura Pauels, MD 3224772344

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CHU Brugmann Recruiting
Brussels, Belgium, 1020
Contact: Pierre Wauthy, MD         
Sponsors and Collaborators
Pierre Wauthy
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Principal Investigator: Laura Pauels, MD CHU Brugmann

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Responsible Party: Pierre Wauthy, Medical Director of the Hospital, Brugmann University Hospital Identifier: NCT03922191     History of Changes
Other Study ID Numbers: CHUB-Pauels
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Mediastinal Diseases
Thoracic Diseases
Respiratory Tract Diseases