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ID
Source
Brief title
Health condition
Elective implant removal (IR) after fracture fixation below the level of the knee
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of patients with a surgical site infection within 90 days
Secondary outcome
- Other infectious outcomes possibly related to the surgeical procedure
- Cost-effectiveness of intervention
- Target-site antibiotic concentrations
- Tissue oxygenation
- Underlying infections
- Independent predictors of SSI
Background summary
Rationale: 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.
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
Study population: Adult patients (>17 y/o) undergoing elective implant removal after fixation of a fracture of foot, ankle, lower leg or patella.
Intervention (if applicable): The intervention group receives 2g of cefazolin as preoperative antibiotic prophylaxis, the control group receives a placebo injection.
Main study parameters/endpoints: the main study parameter is the proportion of patients with a SSI.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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.
Study objective
2gr of Cefazolin is effective as prophylaxis for surgical site infections following implant removal below the level of the knee.
Study design
Start inclusion: January 2020
End of follow up: April 2023 (until 6 months after last IR)
Analysis: May 2023 – July 2023
Implementation: August 2023 – October 2023
Intervention
The intervention group receives 2g of cefazolin as preoperative antibiotic prophylaxis, the control group receives a placebo injection.
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
- A medical history of serious peripheral vascular disease (≥ Fontaine III) Antibiotic treatment at time of IR for a concomitant disease or infection
- A medical history of severe hypersensitivity to penicillin or any other beta-lactam antibiotic
- Severe kidney insufficiency (eGFR < 35)
- Pregnancy and lactation
- Treatment with probenecid, anticoagulants
- 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
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8284 |
| CCMO | NL71051.018.19 |
| OMON | NL-OMON54651 |