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Cloxacillin and drug combination for prevention of postoperative infections in patients undergoing head and neck reconstructive surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on the treatment and prevention of post operative infections, which are infections that can occur after surgery in the head and neck area. The main goal is to find out how much of the antibiotics reach the blood and the surgical site when they are given during the operation.

Participants will receive one of several commonly used antibiotics: amoxicillin combined with clavulanic acid taken by mouth, cloxacillin given through a vein, cefuroxime also given intravenously, and dicloxacillin taken orally. These medicines are standard treatments that doctors use to stop bacteria from growing after surgery.

During the study, small samples of blood (the liquid part of blood called plasma) and fluid from the surgical area will be collected at several time points after the antibiotic is given. The fluid is obtained with a tiny tube that gently draws out fluid from the tissue, a technique called microdialysis, which allows researchers to measure the amount of drug present over time. The collected samples are then analyzed to see how long the drug levels stay above the amount needed to stop bacterial growth.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    After joining the study you will meet the study staff who will confirm that you meet the inclusion criteria and explain the purpose of the trial.

    Baseline measurements will be taken, including a blood sample to assess your health before any medication is given.

  2. Step 2

    Microdialysis catheter placement and initial sampling

    A small catheter will be inserted into the surgical site to collect fluid from the tissue; this technique is called microdialysis and allows measurement of antibiotic levels directly in the tissue.

    Initial tissue fluid and additional blood sample will be collected before any antibiotic is administered.

  3. Step 3

    Start of oral antibiotic regimen

    You will take an oral tablet that contains amoxicillin 1500 mg combined with clavulanic acid 375 mg.

    The tablet is taken by mouth as directed by the study schedule, typically at regular intervals (for example every 8 hours) for the duration defined by the study protocol.

  4. Step 4

    Intravenous antibiotic administration

    You will receive cloxacillin 4 g given intravenously, cefuroxime 4.5 g given intravenously, and dicloxacillin 4 g given intravenously.

    Each infusion is given according to the study schedule, usually as a single dose or repeated doses as specified by the protocol, for the period required by the study.

  5. Step 5

    Repeated blood and tissue sampling

    Throughout the treatment period additional blood samples and tissue fluid collected by the microdialysis catheter will be taken at predefined times.

    These samples are used to measure the concentration of the antibiotics in your blood and in the tissue.

  6. Step 6

    Final assessment and catheter removal

    At the end of the treatment period a final set of samples will be collected.

    The microdialysis catheter will be removed, and a concluding health assessment will be performed to complete your participation in the trial.

Who can join the trial?

4 criteria

  • Signed informed consent – you agree in writing to take part after understanding what the study involves.
  • Having either a post‑operative neck infection (an infection that occurs after neck surgery) or a planned surgery that uses an inferior turbinate flap (IFT flap) – a piece of tissue taken from inside the nose to help rebuild another area.
  • Being at least 18 years old – you must be an adult.
  • Being a man or a woman – the study accepts participants of any gender.

Who cannot join the trial?

3 criteria

  • Having a known allergy or strong reaction (hypersensitivity) to any of the study antibiotics (the medicines called cefuroxime, cloxacillin, dicloxacillin, or amoxicillin/clavulanic acid).
  • Being currently pregnant or planning to become pregnant.
  • Having an eGFR (a test that shows how well the kidneys work) lower than 30 ml/min/1.73 m², which means the kidneys are not functioning well enough.
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Investigated drugs

  • Clavulanic acid

    is a medication that blocks enzymes made by some bacteria that can destroy antibiotics. In this study it is given by mouth to see how much of the drug reaches the blood and the tissue in the head and neck area.

  • Amoxicillin

    is a commonly used antibiotic that kills many types of bacteria. In the trial it is taken orally, and researchers measure how well it moves from the bloodstream into the tissues after surgery.

  • Cloxacillin

    is an antibiotic given through a vein (intravenously) that works against certain bacteria that cause infections. The study looks at how much of this drug enters the blood and the surgical tissue.

  • Cefuroxime

    is a broad‑spectrum antibiotic given by IV that treats a wide range of bacterial infections. The trial checks its levels in plasma and in the head‑neck tissue after it is administered.

  • Dicloxacillin

    is an oral antibiotic that targets bacteria often found in skin and soft‑tissue infections. In this research it is taken by mouth, and its penetration into tissue and blood is measured.

What is already known about the treatment

  • Clavulanic Acid

    This medication is taken by mouth in tablet form, usually together with another antibiotic, and the dose is 375 mg. It is an approved drug that is widely used in medical practice and described in many clinical studies. It helps prevent bacterial infections after surgery by blocking enzymes that would destroy the partner antibiotic, making the treatment work better. It belongs to the class of beta‑lactamase inhibitors, which are added to penicillin‑type drugs to extend their effect.

  • Amoxicillin

    Amoxicillin is given orally as a tablet or liquid, with a typical dose of 1500 mg, and is absorbed through the digestive system. It is a well‑known, approved antibiotic that appears in many medical guidelines and research articles. It treats a broad range of bacterial infections, including those that can occur after operations, by stopping bacteria from building their protective cell walls. It is classified as a penicillin‑type antibiotic.

  • Cloxacillin

    Cloxacillin is administered intravenously, meaning it is injected directly into a vein, usually at a dose of 4 g. It is an established drug that is fully approved and frequently referenced in clinical literature. It is used for serious bacterial infections, especially after surgery, by interfering with the bacteria’s ability to form a strong cell wall, which leads to their death. It belongs to the penicillinase‑resistant penicillin group.

  • Cefuroxime

    Cefuroxime is given by intravenous injection, with a typical dose of 4.5 g, and the drug enters the bloodstream directly. It is an approved second‑generation cephalosporin antibiotic that is well documented in medical research. It helps prevent and treat post‑operative infections by stopping bacteria from constructing their cell walls, which kills the microbes. It is classified as a cephalosporin antibiotic.

  • Dicloxacillin

    Dicloxacillin is taken orally, often as a tablet, with a dose of 4 g, and is absorbed through the gut. It is an approved medication widely used and described in many clinical studies. It is used to treat and prevent infections after surgery by blocking the formation of bacterial cell walls, leading to bacterial death. It belongs to the penicillinase‑resistant penicillin class.

Investigated diseases

Surgical site infection - A surgical site infection is an infection that occurs at the part of the body where a surgery was performed. It can involve the skin, tissue under the skin, or deeper structures such as organs or spaces opened during the operation. The infection usually appears within a few days after surgery and may start with redness, warmth, pain, and swelling at the incision. If the infection spreads, it can lead to the formation of pus, breakdown of tissue, and may extend to surrounding areas. In some cases, the infection can become systemic, causing fever and a general feeling of being unwell.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526995-22-00Protocol code310816Estimated enrolment16 patientsSponsorRegion Midtjylland

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