Antibiotic Tissue Penetration in Head and Neck Infection and Reconstructive Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, non-randomized, open-label interventional study with two sub-studies enrolling 16 adults. It uses microdialysis and serial blood sampling to measure tissue and plasma antibiotic concentrations over a defined dosing period. Sub-study 1 focuses on postoperative neck infection and compares two cefuroxime-based regimens with additional penicillin-type antibiotics. Sub-study 2 evaluates antibiotic penetration in patients undergoing reconstruction with an inferior turbinate flap. The study aims to determine how long drug concentrations stay above the MIC in infected tissue, non-infected tissue, the flap, and plasma, and to describe markers of ischemia and inflammation in the flap during early postoperative days.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed informed consent
* Either a postoperative infection in the neck (sub-study 1) or planned reconstruction with an inferior turbinate flap (sub-study 2)
* Age 18 years or older

Exclusion Criteria:

* Known allergy or hypersensitivity to any of the study antibiotics (cefuroxime, cloxacillin, dicloxacillin, or amoxicillin/clavulanic acid)
* eGFR below 30 mL/min/1.73 m2
* Pregnancy or planned pregnancy

Where it's running

• Aarhus University Hospital, Department of Otorhinolaryngology, Head and Neck Surgery
  Aarhus N, Denmark Recruiting

Study contacts

• Principal investigator: Tejs Ehlers Klug, MD, DMSc — Aarhus University Hospital
• Study coordinator: Pelle Hanberg, MD, PhD
• Email: pellehanberg@clin.au.dk
• Phone: +45 28744852

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.