Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Antibiotic Prophylaxis with Piperacillin, Tazobactam, and Cefazolin for Burn Patients Undergoing Excision-Graft Surgery

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on patients who have suffered from burns and require a specific type of surgery known as *excision-autograft surgery*. This procedure involves removing damaged skin and replacing it with healthy skin from another part of the body. The study aims to evaluate the effectiveness of using *systemic antibiotic prophylaxis* to prevent infections after surgery. The antibiotics being studied are *Piperacillin Tazobactam* and *Cefazolin*. These medications are given through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.

Participants in the study will be randomly assigned to receive either the antibiotics or a placebo, which is a substance with no active medication. The main goal is to see if these antibiotics can reduce the risk of infections, such as *postoperative sepsis* and *autograft lysis*, which is when the new skin graft does not take hold and requires another graft. The study will monitor patients for any signs of infection within seven days after their surgery.

Throughout the study, researchers will also observe other outcomes, such as the overall recovery and healing process, the length of hospital stay, and any potential colonization by *multiresistant bacteria*. The study is designed to provide valuable information on the best ways to prevent infections in burn patients undergoing this type of surgery, ultimately aiming to improve patient care and outcomes.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, burn severity, and the need for excision-graft surgery.

    Informed consent is required, or inclusion is possible under emergency provisions.

  2. Step 2

    Pre-surgery preparation

    Before surgery, preparation involves understanding the procedure and the role of antibiotics in preventing infections.

  3. Step 3

    Surgery and initial treatment

    During the excision-graft surgery, antibiotics are administered to prevent infections.

    The specific antibiotics used are piperacillin sodium and tazobactam sodium, given as a solution for infusion through an intravenous injection.

  4. Step 4

    Post-surgery monitoring

    After surgery, monitoring for infections, sepsis, and graft lysis is conducted for 7 days.

    The goal is to evaluate the effectiveness of the antibiotic prophylaxis in preventing these complications.

  5. Step 5

    Follow-up assessments

    Follow-up assessments occur at various intervals, including 28 and 90 days post-surgery.

    These assessments focus on recovery, any need for additional grafts, and monitoring for infections or antibiotic resistance.

  6. Step 6

    Completion of trial participation

    Participation concludes once all follow-up assessments are completed and data is collected for analysis.

    The trial aims to understand the impact of antibiotics on recovery and infection rates in burn patients.

Who can join the trial?

4 criteria

  • Must be an adult, meaning over 18 years old.
  • Must have burns that need at least one surgery where damaged skin is removed and replaced with a graft, which is a piece of healthy skin taken from another part of the body.
  • The total area of the body affected by burns should be between 5% and 40%.
  • Must have signed a form agreeing to participate, or be included under special emergency rules if unable to sign.

Who cannot join the trial?

4 criteria

  • Patients who are not undergoing excision-autograft surgery for burns. This is a type of surgery where damaged skin is removed and replaced with healthy skin from another part of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who do not belong to the specific clinical trial group being studied.
  • Patients who are not able to give informed consent or are considered part of a vulnerable population.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Systemic Antibiotic Prophylaxis is used in this trial to prevent infections after surgery in burn patients. The goal is to reduce the risk of postoperative infections, sepsis, and the breakdown of skin grafts, which might require additional skin graft surgeries within a week after the initial procedure.

What is already known about the treatment

Antibiotic Prophylaxis – This medication is administered systemically, typically through oral or intravenous routes, to prevent infections in patients undergoing excision-autograft surgery for burns. It is currently being studied in clinical trials to assess its effectiveness in reducing postoperative infections, sepsis, and the need for additional skin grafts. The main therapeutic indication is to prevent infections in burn patients after surgery. The mechanism of action involves inhibiting bacterial growth or killing bacteria, depending on the specific antibiotic used. It is classified pharmacologically as an antibiotic, which is a type of antimicrobial agent.

Investigated diseases

Burn Injury – A burn injury occurs when the skin or other tissues are damaged by heat, chemicals, electricity, sunlight, or radiation. The severity of a burn is determined by its depth and the extent of the body affected. Burns can be classified into first, second, or third degree, with third-degree burns being the most severe, affecting all layers of the skin. As the burn heals, the body may form scar tissue, and in severe cases, skin grafts may be necessary to replace damaged skin. Healing can be complicated by infections, which may require additional medical interventions. The recovery process varies depending on the burn's severity and the individual's overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514349-13-00Protocol codeAPHP180605Estimated enrolment506 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.