NCT03922191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

April 17, 2019

Last Update Submit

July 15, 2019

Conditions

Mediastinitis

Outcome Measures

Primary Outcomes (6)

  • Duration of the hospitalization

    Duration of the hospitalization

    20 years

  • Mortality at six months

    Mortality rate six months after mediastinitis diagnosis

    6 months

  • Percentage of recurrence

    Percentage of recurrence of mediastinitis

    20 years

  • Percentage of re-hospitalization

    Percentage of re-hospitalizations caused by mediastinitis

    20 years

  • Duration of the antibiotic treatment

    Duration of the antibiotic treatment for mediastinitis

    20 years

  • Presence of superinfection

    Presence of superinfection

    20 years

Secondary Outcomes (6)

  • Date of birth

    20 years

  • Sex

    20 years

  • Risk factors

    20 years

  • Surgical intervention

    20 years

  • Germ identification

    20 years

  • +1 more secondary outcomes

Study Arms (2)

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

Data extraction from medical filesOTHER

Data extraction from medical files

Adult populationPediatric population

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of the CHU Brugmann (adults) and HUDERF (pediatric) Hospitals, treated for post-cardiac surgery mediastinitis.

You may qualify if:

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

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Mediastinitis

Condition Hierarchy (Ancestors)

Mediastinal DiseasesThoracic DiseasesRespiratory Tract Diseases

Study Officials

  • Laura Pauels, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Director of the Hospital

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 19, 2019

Study Start

February 12, 2019

Primary Completion

July 15, 2019

Study Completion

July 15, 2019

Last Updated

July 16, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)