Post-Surgical Mediastinitis Within the CHU Brugmann Hospital

Mediastinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922191
• Other study ID #: CHUB-Pauels
• Status: Completed
• Start date: February 12, 2019
• Est. completion date: July 15, 2019

Study information

• Verified date: July 2019
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• post-cardiac surgery mediastinitis

• patients of the CHU Brugmann (adults) and HUDERF (pediatric) Hospitals

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Mediastinitis

Intervention

Other:
• Data extraction from medical files
Data extraction from medical files

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Wauthy

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of the hospitalization	Duration of the hospitalization	20 years
Primary	Mortality at six months	Mortality rate six months after mediastinitis diagnosis	6 months
Primary	Percentage of recurrence	Percentage of recurrence of mediastinitis	20 years
Primary	Percentage of re-hospitalization	Percentage of re-hospitalizations caused by mediastinitis	20 years
Primary	Duration of the antibiotic treatment	Duration of the antibiotic treatment for mediastinitis	20 years
Primary	Presence of superinfection	Presence of superinfection	20 years
Secondary	Date of birth	Demographic data : Date of birth.	20 years
Secondary	Sex	Demographic data : sex.	20 years
Secondary	Risk factors	Demographic data : presence of risk factors (obesity, diabetes...).	20 years
Secondary	Surgical intervention	Name of the surgical intervention that caused the mediastinitis	20 years
Secondary	Germ identification	Name of the germ causing the mediastinitis	20 years
Secondary	Type of treatment	Name of the antibiotics used to treat the mediastinitis	20 years