To analyze the difference in fT>MIC at the target site and infection rate for a single dose of 1 and 2g of cefazolin.
ID
Source
Brief title
Condition
- Fractures
- Skin and subcutaneous tissue disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: fT>MIC at the 'target-site'
Secondary outcome
Secondary outcome: fT>MIC in serum, rate of SSI, correlation between fT>MIC and
infection
Background summary
The incidence of surgical site infections (SSI) in foot and ankle fracture
surgery is high. Below the knee, 1g of prophylactic cefazolin seems to have no
effect on the rate of SSI, even though it has proved to be successful in hip
and knee procedures. When studying concentrations, the amount of cefazolin in
tissue of the foot is up to 30 times lower than in the knee. This suggests that
penetration of antibiotics in more distal parts of the lower limb might be
impaired and a dose of 1g might not be sufficient. To link the concentration of
antibiotics to the antibacterial effect one needs to know the time that the
free proportion of antibiotics exceeds the minimum inhibitory concentration
(fT>MIC). However, to the best of our knowledge, the target site fT>MIC has not
been investigated in trauma/orthopedic surgery, let alone in foot and ankle.
Analyzing the fT>MIC at the target site will provide us with more knowledge
about the optimal dosing and effectiveness of antibiotic prophylaxis at the
target site.
Study objective
To analyze the difference in fT>MIC at the target site and infection rate for a
single dose of 1 and 2g of cefazolin.
Study design
Double blind, randomized controlled superiority trial.
Intervention
Group 1 receives a single dose of 1g of intravenously administered cefazolin,
30 minutes before surgery and group 2 receives a single dose of 2g of
intravenously administered cefazolin, 30 minutes before surgery.
Study burden and risks
Participating in this trial does not propose additional risk to the patient
compared to current practice. Both dosing cefazolin regimens (1g/2g) have
proved to be safe and effective. Samples are all 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. 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
- >17 years old
- Undergoing open surgery of the foot or ankle
Exclusion criteria
- Antibiotic treatment within 7 days before the surgery
- An open fracture
- A medical history of an allergic reaction to a cephalosporin or severe reaction to penicillin, or any other *-lactam antibiotic
- Insufficient comprehension of the Dutch language to understand the patient information to make an informed decision to participate
- Kidney disease (eGFR <60 ml/min/1.73m^2)
- Pregnancy and lactation
- A medical history of Diabetes Mellitus or serious peripheral vascular disease (* Fontaine III)
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 | EUCTR2018-001106-28-NL |
| CCMO | NL65398.018.18 |