ClinicalTrials.gg
CompletedNCT03922191Updated Jul 16, 2019

Post-Surgical Mediastinitis Within the CHU Brugmann Hospital

An observational study in Mediastinitis, sponsored by Pierre Wauthy. Completed at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2019-07-16.

Sponsored by Pierre Wauthy · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
19
Sex
All
01

Study 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.

02

Conditions studied

  • Mediastinitis

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03

In context

Mediastinitis

21 studies on the registry are indexed under Mediastinitis; 3 are open to participants now.

Browse Mediastinitis studies →

Lead sponsor

Pierre Wauthy is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
19 participants (actual)
Patient registry
No

Groups and cohorts

  • Pediatric population

    Infants diagnosed with cardiac post-surgery mediastinitis within the HUDERF Hospital within the last 20 years.

    Other: 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

Interventions

  • OtherData extraction from medical files

    Data extraction from medical files

06

What researchers measure

Primary outcomes

  1. Duration of the hospitalization

    Duration of the hospitalization

    Time frame: 20 years

  2. Mortality at six months

    Mortality rate six months after mediastinitis diagnosis

    Time frame: 6 months

  3. Percentage of recurrence

    Percentage of recurrence of mediastinitis

    Time frame: 20 years

  4. Percentage of re-hospitalization

    Percentage of re-hospitalizations caused by mediastinitis

    Time frame: 20 years

  5. Duration of the antibiotic treatment

    Duration of the antibiotic treatment for mediastinitis

    Time frame: 20 years

  6. Presence of superinfection

    Presence of superinfection

    Time frame: 20 years

Secondary outcomes

  1. Date of birth

    Demographic data : Date of birth.

    Time frame: 20 years

  2. Sex

    Demographic data : sex.

    Time frame: 20 years

  3. Risk factors

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

    Time frame: 20 years

  4. Surgical intervention

    Name of the surgical intervention that caused the mediastinitis

    Time frame: 20 years

  5. Germ identification

    Name of the germ causing the mediastinitis

    Time frame: 20 years

  6. Type of treatment

    Name of the antibiotics used to treat the mediastinitis

    Time frame: 20 years

07

Study locations

1 site
  • CHU Brugmann
    Brussels, 1020, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03922191
Lead sponsor
Pierre Wauthy
Responsible party
Pierre Wauthy (Medical Director of the Hospital, Brugmann University Hospital) — Sponsor-investigator
First posted
Apr 19, 2019
Start date
Feb 12, 2019
Primary completion
Jul 15, 2019
Completion
Jul 15, 2019
Last update
Jul 16, 2019

Study contacts

Laura Pauels, MD
principal investigator · CHU Brugmann

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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