Antibiotic prophylaxis and prevention of wound infections following implant removal after foot, ankle and lower leg fractures

Antibiotic prophylaxis and prevention of wound infections following implant removal after foot, ankle and lower leg fractures - WIFI-trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44330

Enrollment

500

Registered

2014-10-07

Start date

2014-11-12

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

postoperative wound infection

Interventions

Patients will be randomly assigned to implant removal with administration of a single dose intravenous antibiotic prophylaxis (cefalozin) or a matching 10 cc NaCl 0.9% by use of a web-based randomiza

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Implant removal in foot, ankle and lower leg in patients *18 years and *75 years of all ethnic backgrounds

Exclusion criteria

Exclusion criteria: - Removing and re-implanting material in the same session - Implant removal due to active infection - Implant removal due to a (plate) fistula - Current antibiotic treatment - Allergy to cephalosporines

Design outcomes

Primary

Measure	Time frame
The primary outcome is the incidence of wound infection (within 30 days after implant removal) as defined by the criteria applied by the CDC and diagnosed by the attending physician.	—

Secondary

Measure	Time frame
Secondary outcomes are health-related quality of life (as measured by the EQ-5D), functional outcome (assessed with the Lower Extremity Functional Scale), patient satisfaction (measured by a ten-point Visual Analog Scale), several treatment and function related items (including amongst others, number of visits to the general practitioner and use of home care organizations) measured at 30 days and 6 months postoperatively, as well as costs (e.g. production losses due to sick leave). In addition, the incidence of micro-bacterial growth in cultures taken peroperatively (evaluation between patients with and without antibiotic prophylaxis) and diversity of micro bacterial growth in postoperative wound infection will be documented.	—

Measure

Time frame

Secondary outcomes are health-related quality of life (as measured by the EQ-5D), functional outcome (assessed with the Lower Extremity Functional Scale), patient satisfaction (measured by a ten-point Visual Analog Scale), several treatment and function related items (including amongst others, number of visits to the general practitioner and use of home care organizations) measured at 30 days and 6 months postoperatively, as well as costs (e.g. production losses due to sick leave). In addition, the incidence of micro-bacterial growth in cultures taken peroperatively (evaluation between patients with and without antibiotic prophylaxis) and diversity of micro bacterial growth in postoperative wound infection will be documented.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)