Can we improve the prophylactic profile of antibiotic treatment in shoulder prosthesis surgery?- A clinical microdialysis study assessing antibiotic concentrations in deadspace, bone, and soft tissue following weight-based cefuroxime dosage in both anatomic and reverse shoulder prosthesis surgery.
Phase 1
- Conditions
- Orthopedic infectionsMedDRA version: 21.0Level: LLTClassification code 10021799Term: Infection and inflammatory reaction due to other internal orthopedic device, implant, and graftSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2020-003078-36-DK
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Signed informed consent.
- Age minimum 18 years.
- Elektiv RSA or ASA at the Department of Orthopedic Surgery, Aarhus University Hospital.
- Normal kidney numbers prior to surgery(eGFR and kreatinin).
- Fertile women have to use safe contraception prior to surgery, or a negative pregnancy-test on the day of surgery.
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 10
Exclusion Criteria
- Allergy towards cefuroxime.
- Treatment with cefuroxime or meropeneme 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
- Secondary Outcome Measures
Name Time Method