Do use of torniquete reduce the impact of the antibiotic treatment during orthopedic treatment?

Do use of torniquete reduce the impact of the antibiotic treatment during orthopedic treatment? - KABALE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000217-21-DK

Enrollment

Registered

2018-02-01

Start date

2018-03-22

Completion date

Unknown

Last updated

2020-11-09

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 10019095 Term: Hallux Valgus correction 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: - Signed informed consent - Age = 18 years - Normal distal blood preasure bilateral - Normal kidney numbers - Fertile women have to use safe contraception. 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 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1

Exclusion criteria

Exclusion criteria: - Previouse surgery of the arteries in the leg (concerns both legs) - Previouse surgery of the calcaneus (concerns both legs) - Previouse bone infections or fracture of the calcaneus (concerns both legs) - Diabetes - unsuccessful spinal anaesthesia - Allergy to cefuroxime

Design outcomes

Primary

Measure	Time frame
Main Objective: The objectives of this trial is to asses the penetration of cefuroxime into muscle, subcutaneous and bone tissue using the pharmacokinetic tool microdialysis, and to see how the use of torniquete affects the penetration and the ischaemic markers. The primary endpoints are the time for which the cefuroxime concentration is maintained above the minimal inhibitory concentration (T>MIC), penetrations ratios and the iscaemic markers. Secondary endpoints are standard pharmacokinetic parameters (eg. half-life, Cmax, Tmax and AUC). ;Secondary Objective: not applicable ;Primary end point(s): The primary endpoints are the time for which the cefuroxime concentration is maintained above the minimal inhibitory concentration (T>MIC), penetrations ratios and the iscaemic markers.;Timepoint(s) of evaluation of this end point: At the end of the study	—

Measure

Time frame

Main Objective: The objectives of this trial is to asses the penetration of cefuroxime into muscle, subcutaneous and bone tissue using the pharmacokinetic tool microdialysis, and to see how the use of torniquete affects the penetration and the ischaemic markers. The primary endpoints are the time for which the cefuroxime concentration is maintained above the minimal inhibitory concentration (T>MIC), penetrations ratios and the iscaemic markers. Secondary endpoints are standard pharmacokinetic parameters (eg. half-life, Cmax, Tmax and AUC). ;Secondary Objective: not applicable ;Primary end point(s): The primary endpoints are the time for which the cefuroxime concentration is maintained above the minimal inhibitory concentration (T>MIC), penetrations ratios and the iscaemic markers.;Timepoint(s) of evaluation of this end point: At the end of the study

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints are standard pharmacokinetic parameters (eg. half-life, Cmax, Tmax and AUC).;Timepoint(s) of evaluation of this end point: At the end of the study	—

Countries

Denmark

Contacts

Public ContactPelle Hanberg

Horsens Regional Hospital

pellehanberg@clin.au.dk004528744852

Outcome results

None listed

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