The primary objective is to study the effectiveness of a single intravenous dose of 2g of cefazolin on SSIs after IR following fixation of foot, ankle and/or lower leg fractures. Secondary objectives are to study the cost-effectiveness of 2g of…
ID
Source
Brief title
Condition
- Fractures
- Skin and subcutaneous tissue disorders NEC
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the main study parameter is the number of SSIs
Secondary outcome
Secondary outcomes are the cost-effectiveness of 2g of cefazolin, the
underlying mechanism of prophylactic antibiotics (target-site antibiotic
concentrations and tissue oxygenation), underlying infections, and independent
predictors of SSI.
Background summary
Elective implant removal (IR) after fracture fixation is one of the most common
procedures within the orthopaedic/trauma surgery. The rate of surgical site
infections (SSIs) in this procedure is quite high, especially below the level
of the knee. Antibiotic prophylaxis is not routinely prescribed, even though it
has proved to lower SSI rates in other orthopaedic/ trauma surgical procedures.
Study objective
The primary objective is to study the effectiveness of a single intravenous
dose of 2g of cefazolin on SSIs after IR following fixation of foot, ankle
and/or lower leg fractures. Secondary objectives are to study the
cost-effectiveness of 2g of cefazolin preventing SSIs after IR, to study
target-site antibiotic concentrations and tissue oxygenation, to identify
underlying infections, and to identify independent predictors of SSI.
Study design
This is a multicenter, double-blind placebo controlled intervention study
Intervention
The intervention group receives 2g of cefazolin as preoperative antibiotic
prophylaxis, the control group receives a placebo injection.
Study burden and risks
Participating in this trial does not propose additional risk to the patient
compared to current practice. Cefazolin has proved to be safe and effective as
preoperative antibiotic prophylaxis in this dose. The burden is low for most
patients as extra visits to the hospital are not required and questionnaires
will take approximately 60 minutes in total. Additional measurements are only
applicable to a small proportion of participants at the Amsterdam UMC. For
these patients, blood samples will be obtained during surgery, under general or
regional anaesthesia and include 3-4 serum samples, 2 target-site blood samples
and 2 target-site soft tissue samples. Moreover patients will undergo
continuous subcutaneous tissue oxygen tension measurements and measurements of
haemoglobin oxygenation in the local microcirculation of the contralateral
foot. No extra visits to the outpatient clinic are required when participating
in the trial.
Meibergdreef 9
Amsterdam-Zuidoost 1105 AZ
NL
Meibergdreef 9
Amsterdam-Zuidoost 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Aged between 18 and 75 years
- Scheduled for IR following fracture surgery of the patella, lower leg, ankle
or foot
Exclusion criteria
- Removing and re-implanting osteosynthetic material in the same session -
Active wound infection or (plate) fistula - Antibiotic treatment at time of IR
for a concomitant disease or infection - A medical history of serious
peripheral vascular disease (>= Fontaine III) - A medical history of severe
hypersensitivity to penicillin or any other beta-lactam antibiotic - Severe
kidney insufficiency (eGFR < 35) - Pregnancy - Treatment with probenecid (see
SPC) - Immunosuppressant use in organ transplantation or rheumatoid joint
disease - Insufficient comprehension of the Dutch/English language to
understand the patient information to make an informed decision to participate
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-003105-10-NL |
| CCMO | NL71051.018.19 |
| OMON | NL-OMON20062 |