Post-Surgical Mediastinitis Within the CHU Brugmann Hospital

Post-Surgical Mediastinitis: Retrospective Study of Cases Treated 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.

Study Overview

• Status: Completed
• Conditions: Mediastinitis
• Intervention / Treatment: Other: Data extraction from medical files

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

- none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Date of birth	Demographic data : Date of birth.	20 years
Sex	Demographic data : sex.	20 years
Risk factors	Demographic data : presence of risk factors (obesity, diabetes...).	20 years
Surgical intervention	Name of the surgical intervention that caused the mediastinitis	20 years
Germ identification	Name of the germ causing the mediastinitis	20 years
Type of treatment	Name of the antibiotics used to treat the mediastinitis	20 years

Collaborators and Investigators

• Sponsor: Pierre Wauthy
• Investigators: Principal Investigator: Laura Pauels, MD, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2019
• Primary Completion (Actual): July 15, 2019
• Study Completion (Actual): July 15, 2019

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Mediastinal Diseases; Thoracic Diseases; Mediastinitis
• Other Study ID Numbers: CHUB-Pauels

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No