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Local gentamicin in Redon treated post-sternotomy mediastinitis

Local gentamicin in Redon treated post-sternotomy mediastinitis - GentaTrial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41174
Enrollment
40
Registered
2014-09-17
Start date
2015-03-03
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Post-sternotomy mediastintis surgical site infection after cardiac surgery

Interventions

Patients in the treatment group receive two collagenous drug carriers loaded with gentamicin between the sternal halves before closure. Patients in the control group are closed as usual.

Sponsors

Sint Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age above 18 years - Underwent a cardiothoracic procedure through median sternotomy - Clinical signs of PSM as described by the Centres for Disease Control and Prevention (CDC)

Exclusion criteria

Exclusion criteria: - Patients with severe renal failure (serum creatinine above 150 µmol/L) - Patients with neuromuscular diseases - Patients who are allergic for aminoglycosides - Patients with systemic lupus erythematosus, scleroderma or chronic polyarthritis

Design outcomes

Primary

MeasureTime frame
Hospital stay

Secondary

MeasureTime frame
In-hospital mortality Duration of wound sterilization Duration of antibiotic treatment Duration of drainage CRP decline Leukocyte decline

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)