Wound Infections following Implant Removal below the level of the knee; the influence of 2g of prophylactic Cefazoli

Recruiting

Conditions: surgical site infection
postoperative wound infection
10017322
10040792
10005944

Registration Number: NL-OMON54651

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 732

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>the main study parameter is the number of SSIs</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are the cost-effectiveness of 2g of cefazolin, the<br /><br>underlying mechanism of prophylactic antibiotics (target-site antibiotic<br /><br>concentrations and tissue oxygenation), underlying infections, and independent<br /><br>predictors of SSI.</p><br>