Prevention of infection in orthopaedic spine surgery - a clinical study of antibiotic concentrations spine tissue after administration of antibiotics dosed by bodyweight

Phase 1

• Conditions: Orthopaedic infections.; MedDRA version: 20.0Level: LLTClassification code 10049130Term: Back surgerySystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2020-004004-34-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-30
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

- Sign informed consent (and sign informed consent by parents with child custody when participants are under 18 years of age).
- Planned spine deformity surgery at the Department of Orthopaedic Surgery, Aarhus University Hospital
- Normal preoperative kidney function (assessed by eGFR, P-creatinin)
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Fertile women may not be pregnant (asked about the likelihood of pregnancy at preliminary visit and offered preoperative plasma hCG for clarification if in doubt).
- Allergy towards cefuroxime.
- Antibiotic treatment with cefuroxime 4 days prior to surgery.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified