Does repeated administration of cefuroxime after orthopedic surgery provide a better prophylactic profile regarding postoperativ infection than a single administration of preoperative antimicrobial ? - A micro dialysis study assessing the concentration of antibiotics in bone, synovial sheath, and subcutaneous tissue after trapeziectomy

Does repeated administration of cefuroxime after orthopedic surgery provide a better prophylactic profile regarding postoperativ infection than a single administration of preoperative antimicrobial ? - A micro dialysis study assessing the concentration of antibiotics in bone, synovial sheath, and subcutaneous tissue after trapeziectomy - MANUS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001134-33-DK

Enrollment

Registered

2019-03-15

Start date

2019-06-18

Completion date

Unknown

Last updated

2021-08-17

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

Conditions

Orthopedic infections. MedDRA version: 20.0 Level: LLT Classification code 10043658 Term: Thumb osteoarthritis System Organ Class: 100000004859

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: - signed informed consent - age minimun 18 years - elective trapeziectomy at the Department of Orthopedic Surgery, Aarhus University Hospital - Normal liver- and kidney numbers - Fertile women have to use safe contraception. Fertile women, who do not use safe contraception will have to perform a urin-hCG. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: - Allergy towards antibiotics from the group of beta-lactams (penicillins, cephalosporins, and carbapenems) - Diabetes - Previous surgery of the 1. metacarp (concerns the operated hand) - Previous fracture of the 1. metacarp (concerns the operated hand) - Previous surgery of the arteries in the arm (concerns the operated hand) - Treatment with cefuroxime 4 days prior to the surgery

Design outcomes

Primary

Measure	Time frame
Main Objective: The objectives of the trial are to asses the penetration of cefuroxime when it is administered as either a single administration or as repeated administration, into bone, synovial sheath, and subcutaneous tissue with the use of the pharmacokinetic sampling method, micro dialysis. The primary endpoints are the time for which the concentration of cefuroxime is above the minimal inhibitory concentration (T>MIC) and penetration ratios. The secondary endpoints are standard pharmacokinetic parametres such as; half-life, Cmax, Tmax and AUC. ;Secondary Objective: not applicable. ;Primary end point(s): The primary endpoints are the time for which the concentration of cefuroxime is maintained above til minimal inhibitory concentration (T>MIC) and penetration ratios. ;Timepoint(s) of evaluation of this end point: Endpoints will be evaluated at the end of the study.	—

Measure

Time frame

Main Objective: The objectives of the trial are to asses the penetration of cefuroxime when it is administered as either a single administration or as repeated administration, into bone, synovial sheath, and subcutaneous tissue with the use of the pharmacokinetic sampling method, micro dialysis. The primary endpoints are the time for which the concentration of cefuroxime is above the minimal inhibitory concentration (T>MIC) and penetration ratios. The secondary endpoints are standard pharmacokinetic parametres such as; half-life, Cmax, Tmax and AUC. ;Secondary Objective: not applicable. ;Primary end point(s): The primary endpoints are the time for which the concentration of cefuroxime is maintained above til minimal inhibitory concentration (T>MIC) and penetration ratios. ;Timepoint(s) of evaluation of this end point: Endpoints will be evaluated at the end of the study.

—

Secondary

Measure	Time frame
Secondary end point(s): Standard pharmacokinetic parametres: half life, Cmax, Tmax, and AUC. ;Timepoint(s) of evaluation of this end point: Endpoints will be evaluated at the end of the study.	—

Countries

Denmark

Contacts

Public ContactAndrea René Jørgensen

Aarhus University Hospital

anjo@clin.au.dk004551955640

Outcome results

None listed

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