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

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What is this study about?

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.

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 pre-surgery preparation

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

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Hospital Edouard Herriot Lyon France
HIA Sainte Anne Toulon France
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Beaujon Clichy France
Centre Hospital Region Metz Thionville Metz France
Acghyqhuqf Pkvdmvnf Helhhdfo Di Mtxkznwco Marseille France
Cafeqh Hmrsrlutxne Rxakvwjt Ufhlvwkinssav Df Tjnbe Tours France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
11.10.2020

Trial locations

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.

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 ID:
2024-514349-13-00
Protocol code:
APHP180605
NCT ID:
NCT04292054
Trial Phase:
Therapeutic confirmatory (Phase III)

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