The aim of this study is to compare the clinical outcome and survival in patients undergoing sternal closure treatment or conventional treatment for postoperative mediastinitis. The secondary objective is to determine incidence of mediastinitis and…
ID
Source
Brief title
Condition
- Other condition
- Thoracic disorders (excl lung and pleura)
- Breast therapeutic procedures
Synonym
Health condition
mediastinitis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical outcome and survival of the two groups: conventional versus closed
sternum treatment. Outcome and survival will be determined by mortality rate,
sternal closure, pain or loss of function, ability to perform same preoperative
activities (work/hobby), clinical data.
Secondary outcome
Clinical outcome and survival of the subgroups of conventional treatment:
omentum flap reconstruction, pectoral flap reconstruction, irrigation system
and open wound treatment.
Other secondary parameters will be occurrence of mediastinitis to determine
incidence and possible risk factors for mediastinitis, such as diabetes,
BMI>30, COPD and number of sternal wires.
Background summary
Mediastinitis after sternotomy is a rare, but devastating complication of
cardiac surgery. Postoperative mediastinitis occurs in 0,75 to 5% of patients
receiving cardiac surgery. The mortality, however, is high. Different studies
report a mortality varying between 9,8 and 15%. Furthermore, postoperative
mediastinitis is associated with prolonged hospital stay, an increased cost of
care and a significant impairment in long-term survival.
Although a wide range of wound-healing strategies has been established, there
is no general consensus regarding the appropriate surgical approach to
mediastinitis following open-heart surgery.
Before 2003, the treatment of postoperative mediastinitis consisted of
cooperation with a plastic surgeon, who performed a reconstruction with a
vascularised soft tissue flap, followed by closing the defect with a split-skin
graft. The flap used consisted of pectoral muscle flap, omentum or a
combination of those two. The sternum remained open, thus was not fixated.
Other treatment modalities used in this period were a closed irrigation system
and open wound treatment.
After this period all postoperative mediastinitis patients were treated with
Vacuum Assisted Closure therapy (VAC-therapy), followed by sternal closure and
a reconstruction with a partial pectoral muscle flap and immediate closure of
the soft tissue defect.
To decide which therapy is more successful every group will be retrospectively
analyzed and compared.
We expect a better result for patients treated after 2003, because of the
re-establishment of normal chest stability by closing the sternum. Therefore we
expect a shorter time of treatment, a decline in morbidity and an improvement
of the well-being of the patients
Study objective
The aim of this study is to compare the clinical outcome and survival in
patients undergoing sternal closure treatment or conventional treatment for
postoperative mediastinitis.
The secondary objective is to determine incidence of mediastinitis and risk
factors for mediastinitis. Furthermore we will compare the subgroups of the
conventional treatment group with the sternal closure group.
Study design
The design of the study is a retrospective, single-center analysis of medical
records of patients diagnosed with postoperative mediastinitis. Follow-up will
be done using two questionnaires.
Study burden and risks
Because consensus is not yet achieved regarding the best treatment of
postoperative mediastinitis, it is important to ask about the patients'
experiences and opinion. The result of the treatment is the most important
outcome and the patient is the only one who can decide if it is acceptable or
not. The time burden is minimal: only 20-30 minutes in total. The emotional
burden could be bigger, because the questionnaires focus on a difficult period.
We also ask the patients about abilities they lost because of the treatment. On
the other hand, this questionnaire could be a way for patients to expel their
(dis)content.
Albinusdreef 2
2333 ZA Leiden
Nederland
Albinusdreef 2
2333 ZA Leiden
Nederland
Listed location countries
Age
Inclusion criteria
All patients diagnosed with postoperative mediastinitis receiving one of the following treatments:
- reconstruction with a vascularised soft tissue flap (omentum and/or pectoral muscle flap), followed by closure with a split-skin graft
- closed irrigation system
- open wound treatment
- VAC-therapy, followed by sternal closure and a reconstruction with a partial pectoral muscle flap and immediate closure of the soft tissue defect
Exclusion criteria
- all patients diagnosed with postoperative mediastinitis not receiving one of the above treatments (e.g. VAC-therapy only);- patients diagnosed with postoperative mediastinitis who died before receiving treatment
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL18611.058.07 |