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

Phase 1

• Conditions: Orthopedic infections.; MedDRA version: 20.0Level: LLTClassification code 10043658Term: Thumb osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-001134-33-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-15
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

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

- 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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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. <br>;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 Outcome Measures

Name	Time	Method
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.