MediastinitisNCT03922191
Post-Surgical Mediastinitis Within the CHU Brugmann Hospital
An observational study of Mediastinitis, run by Pierre Wauthy at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mediastinitis
- What is being tested?
- Data extraction from medical files
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Feb 2019to 15 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of the CHU Brugmann (adults) and HUDERF (pediatric) Hospitals, treated for post-cardiac surgery mediastinitis.
Who may be able to join
- post-cardiac surgery mediastinitis
- patients of the CHU Brugmann (adults) and HUDERF (pediatric) Hospitals
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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...).
Read more
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.
- Conditions
- Mediastinitis
- Being tested
- Data extraction from medical files
- Medical subject headings
- Mediastinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data extraction from medical filesOther
Data extraction from medical files
| Study group | Role | What they receive |
|---|---|---|
| Pediatric population | Infants diagnosed with cardiac post-surgery mediastinitis within the HUDERF Hospital within the last 20 years. Receives: 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. Receives: Other: Data extraction from medical files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the hospitalization
Duration of the hospitalization
Measured: 20 years
Mortality at six months
Mortality rate six months after mediastinitis diagnosis
Measured: 6 months
Percentage of recurrence
Percentage of recurrence of mediastinitis
Measured: 20 years
Percentage of re-hospitalization
Percentage of re-hospitalizations caused by mediastinitis
Measured: 20 years
Duration of the antibiotic treatment
Duration of the antibiotic treatment for mediastinitis
Measured: 20 years
Presence of superinfection
Presence of superinfection
Measured: 20 years
Secondary outcomes (6)
Date of birth
Demographic data : Date of birth.
Measured: 20 years
Sex
Demographic data : sex.
Measured: 20 years
Risk factors
Demographic data : presence of risk factors (obesity, diabetes...).
Measured: 20 years
Surgical intervention
Name of the surgical intervention that caused the mediastinitis
Measured: 20 years
Germ identification
Name of the germ causing the mediastinitis
Measured: 20 years
Type of treatment
Name of the antibiotics used to treat the mediastinitis
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start12 Feb 2019
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MediastinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Wauthy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pierre Wauthy, Brugmann University Hospital
- Investigators
- Laura Pauels, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922191
- Sponsor's protocol ID
- CHUB-Pauels
- Status last verified
- Jul 2019
- First submitted
- 17 Apr 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Surgical Mediastinitis: Retrospective Study of Cases Treated Within the CHU Brugmann Hospital
- ClinicalTrials.gov ID
- NCT03922191
- Acronym / sponsor ID
- CHUB-Pauels
- Conditions
- Mediastinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Pierre WauthyUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric population | – | Other: Data extraction from medical filesInfants diagnosed with cardiac post-surgery mediastinitis within the HUDERF Hospital within the last 20 years. |
| Adult population | – | Other: Data extraction from medical filesAdults diagnosed with cardiac post-surgery mediastinitis within the CHU Brugmann Hospital within the last 20 years. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of the CHU Brugmann (adults) and HUDERF (pediatric) Hospitals, treated for post-cardiac surgery mediastinitis.
Key inclusion criteria (2 listed)
- post-cardiac surgery mediastinitis
- patients of the CHU Brugmann (adults) and HUDERF (pediatric) Hospitals
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data extraction from medical filesData extraction from medical files | Other | Adult population, Pediatric population |
Primary outcome
Duration of the hospitalization
Time frame: 20 years
Duration of the hospitalization
Mortality at six months
Time frame: 6 months
Mortality rate six months after mediastinitis diagnosis
Percentage of recurrence
Time frame: 20 years
Percentage of recurrence of mediastinitis
Percentage of re-hospitalization
Time frame: 20 years
Percentage of re-hospitalizations caused by mediastinitis
Duration of the antibiotic treatment
Time frame: 20 years
Duration of the antibiotic treatment for mediastinitis
Presence of superinfection
Time frame: 20 years
Presence of superinfection
6 secondary outcomes
Date of birth
Time frame: 20 years
Sex
Time frame: 20 years
Risk factors
Time frame: 20 years
Surgical intervention
Time frame: 20 years
Germ identification
Time frame: 20 years
Type of treatment
Time frame: 20 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Pauels, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mediastinitis, run by Pierre Wauthy at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of the hospitalization (time frame: 20 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.