Vacuum-Assisted Closure versus Closed Drainage using Redon Catheters for the Treatment of Mediastinitis: a Prospective Study
Completed
- Conditions
- sternum infection10005944mediastinitis10013369
- Registration Number
- NL-OMON30622
- Lead Sponsor
- cardioth chir
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
All patients that developed mediastinitis after cardiac surgery that need re-sternotomy and fulfill the criteria of mediastinitis according to the guidelines of the US Centers for Disease Control and Prevention (CDC): (1) an organism was isolated from culture of mediastinal tissue or fluid (2) evidence of mediastinitis was seen during the operation (3) one of the following conditions, chest pain, sternal instability, or fever (> 38) was present and there was either purulent discharge from the mediastinum or an organism isolated from blood culture or culture of drainage of the mediastinal area.
Exclusion Criteria
Patients who are mentally not able to chose whether to be involved in the study or not.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>.Primary: to compare discharge after vacuum-assisted drainage or redon<br /><br>drainage.</p><br>
- Secondary Outcome Measures
Name Time Method <p>· 2 en 5-year survival (Kaplan Meier analysis)<br /><br>· Quality of life (QLQ-C30 en C13)<br /><br>· Duration of wound healing (termination VAC therapy, removal of redon drains)<br /><br>· Freedom from mediastinal microbiological cultures<br /><br>· Freedom from re-intervention<br /><br>· CRP<br /><br>· Failure of treatment.</p><br>