Clinical Outcome of Postoperative Mediastinitis: Sternal Closure Versus Conventional Treatment
- Conditions
- mediastinitissternal infection1001336910006295
- Registration Number
- NL-OMON30893
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 80
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Clinical outcome and survival of the two groups: conventional versus closed<br /><br>sternum treatment. Outcome and survival will be determined by mortality rate,<br /><br>sternal closure, pain or loss of function, ability to perform same preoperative<br /><br>activities (work/hobby), clinical data.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Clinical outcome and survival of the subgroups of conventional treatment:<br /><br>omentum flap reconstruction, pectoral flap reconstruction, irrigation system<br /><br>and open wound treatment.<br /><br>Other secondary parameters will be occurrence of mediastinitis to determine<br /><br>incidence and possible risk factors for mediastinitis, such as diabetes,<br /><br>BMI>30, COPD and number of sternal wires.</p><br>