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

Wound Infections following Implant Removal below the level of the knee; the influence of 2g of prophylactic Cefazolin - WIFI-2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54651

Enrollment

732

Registered

2019-10-15

Start date

2020-02-19

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

surgical site infection

Interventions

The intervention group receives 2g of cefazolin as preoperative antibiotic prophylaxis, the control group receives a placebo injection.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Aged between 18 and 75 years - Scheduled for IR following fracture surgery of the patella, lower leg, ankle or foot

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
the main study parameter is the number of SSIs	—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 9, 2026