Skip to content

Vacuum-Assisted Closure versus Closed Drainage using Redon Catheters for the Treatment of Mediastinitis: a Prospective Study

Vacuum-Assisted Closure versus Closed Drainage using Redon Catheters for the Treatment of Mediastinitis: a Prospective Study - VAC study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30622
Enrollment
50
Registered
2007-07-31
Start date
2008-08-23
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mediastinitis sternum infection

Interventions

Vacuum-Assisted Closure versus Closed Drainage using Redon Catheters .

Sponsors

cardioth chir
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Patients who are mentally not able to chose whether to be involved in the study or not.

Design outcomes

Secondary

MeasureTime frame
· 2 en 5-year survival (Kaplan Meier analysis) · Quality of life (QLQ-C30 en C13) · Duration of wound healing (termination VAC therapy, removal of redon drains) · Freedom from mediastinal microbiological cultures · Freedom from re-intervention · CRP · Failure of treatment.

Primary

MeasureTime frame
.Primary: to compare discharge after vacuum-assisted drainage or redon drainage.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)