Systemic absOrption of Locally AdministeRed antibiotics (SOLAR) from the fracture site in adults with an open fracture or fracture-related infection; a prospective cohort study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22256

Enrollment

Registered

2021-06-30

Start date

2021-06-30

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Fracture related infection

Interventions

Local administration of antibiotics at (infected) fracture site

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age 16 years or older 2) Local antibiotic administered as part of the treatment for open fracture or FRI 3) Written informed consent by patient or proxy

Exclusion criteria

Exclusion criteria: 1) Simultaneous systemic administration of same antibiotic 2) Insufficient understanding of Dutch or English language 3) Expected problems with maintaining follow-up

Design outcomes

Primary

Measure	Time frame
Systemic concentration of the locally administered antibiotic	—

Secondary

Measure	Time frame
- Occurrence of antibiotic-related adverse events (nephrotoxicity), defined as an acute kidney injury (AKI) within 3 months of follow-up - (Re)occurrence of FRI within 3 months of follow-up	—

Contacts

Public ContactProf. M.H.J. Verhofstad

Erasmus MC, University Medical Center Rotterdam

m.verhofstad@erasmusmc.nl+31107031050

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)