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

Prevention of infection in orthopaedic spine surgery - a clinical study antibiotic concentrations of in spine tissue after administration of weight-dosed antibiotics - SPINE STUDY

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004004-34-DK

Enrollment

Registered

2020-08-30

Start date

2020-11-11

Completion date

Unknown

Last updated

2020-11-30

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

Conditions

Orthopaedic infections. MedDRA version: 20.0 Level: LLT Classification code 10049130 Term: Back surgery System Organ Class: 100000004865

Interventions

Trade Name: Cefuroxime Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion INN or Proposed INN: Cefuroxime CAS Number: 55268-75-2 Other descriptive name: CEFUROXIME Conce

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate concentrations of the antibiotic cefuroxime in tissue of the spine in patients (adolescents and adults) undergoing spine deformity surgery after administration of weight-dosed cefuroxime. ;Secondary Objective: Use the pharmacokinetic results to evaluate the current guidelines for perioperative dosing of cefuroxime.;Primary end point(s): The time for which the concentration of cefuroxime is maintained above minimal inhibitory concentration (T>MIC) measured over a maximum of 12 hours after placement of microdialysis catheter in bone, paravertebral muscle, subcutis and wound.;Timepoint(s) of evaluation of this end point: Endpoints will be evaluated at the end of the study.	—

Measure

Time frame

Main Objective: To investigate concentrations of the antibiotic cefuroxime in tissue of the spine in patients (adolescents and adults) undergoing spine deformity surgery after administration of weight-dosed cefuroxime. ;Secondary Objective: Use the pharmacokinetic results to evaluate the current guidelines for perioperative dosing of cefuroxime.;Primary end point(s): The time for which the concentration of cefuroxime is maintained above minimal inhibitory concentration (T>MIC) measured over a maximum of 12 hours after placement of microdialysis catheter in bone, paravertebral muscle, subcutis and wound.;Timepoint(s) of evaluation of this end point: Endpoints will be evaluated at the end of the study.

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Secondary

Measure	Time frame
Secondary end point(s): - Pharmacokinetic parameters in plasma, bone tissue, paravertebral muscle, subcutaneous tissue and the wound. - Parameters of ischemia and inflammation in plasma, bone tissue, paravertebral muscle, subcutaneous tissue and the wound. ;Timepoint(s) of evaluation of this end point: Endpoints will be evaluated at the end of the study.	—

Countries

Denmark

Contacts

Public ContactMagnus A. Hvistendahl

Aarhus University Hospital

201709851@post.au.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026