Skip to content

Clinical Outcome of Postoperative Mediastinitis: Sternal Closure Versus Conventional Treatment

Clinical Outcome of Postoperative Mediastinitis: Sternal Closure Versus Conventional Treatment - Mediastinitis and sternal closure

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON30893
Enrollment
80
Registered
2008-02-26
Start date
2007-09-01
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 mediastinitis sternal infection

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)