The aim of our study is to evaluate clinical outcomes of patients primarily closed over Redon catheters for the treatment of PSM, comparing the application of local gentamicin with a control group.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Procedural related injuries and complications NEC
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hospital stay
Secondary outcome
In-hospital mortality
Duration of wound sterilization
Duration of antibiotic treatment
Duration of drainage
CRP decline
Leukocyte decline
Background summary
Post-sternotomy mediastinitis (PSM) is a severe complication of open heart
surgery with low incidence, but high mortality rates, up to 25%. Nowadays both
VAC-therapy and Redon therapy are used to treat PSM. These treatment methods
resulted in a decreased mortality rate of PSM till respectively 13% and 14% in
the St. Antonius Hospital. In Redon treated PSM the sternum is closed
primarily, leaving 2-8 drains in the infected area. No wound debridement and
shorter length of treatment are the benefits of using this technique over
VAC-therapy for the treatment of PSM.
To date just one study used local gentamicin in the treatment of PSM. In this
study 42 mediastinitis patients were primarily closed over high suction Redon
catheters, leaving gentamicin between the sternal halves. Mean duration of
wound sterilization was 25.7 +- 8.6 hours. Duration of hospital stay was 14 +-
5.8 days. There was no mortality. Although this was a retrospective study, the
results are very promising. Both duration of wound sterilization and hospital
stay are significantly shorter compared with the results of Redon treated
patients in St. Antonius and Amphia hospital, with a wound sterilization time
of approximately 26 days and a hospital stay of 33 days.
Study objective
The aim of our study is to evaluate clinical outcomes of patients primarily
closed over Redon catheters for the treatment of PSM, comparing the application
of local gentamicin with a control group.
Study design
Randomized controlled single blind trial
Intervention
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.
Study burden and risks
Patients in the treatment group receive two collagenous drug carriers loaded
with gentamicin. Risks of the application of this drug carrier are minimal. The
drug carrier is approved for the Dutch market for this indication. The control
group will receive standard treatment. There will be no extra physical
examinations, no extra tests and no questionnaires or diaries. There is no
physical or physiological discomfort associated with participation.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
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
- 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-001170-33-NL |
| CCMO | NL48656.100.14 |