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Study on Cefoxitin and Sodium Chloride for Preventing Infections After Colorectal Surgery

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on preventing infections that can occur after surgery on the colon or rectum, known as colorectal surgery. The study is investigating the use of a medication called cefoxitin, which is an antibiotic that helps fight bacteria. The trial will compare two different ways of giving this medication: one group will receive it in regular doses, while the other group will receive an initial larger dose followed by a continuous infusion. The goal is to see which method is more effective in preventing infections at the site of surgery.

Participants in the study will be adults undergoing colorectal surgery. The study will last for a period of time after the surgery to monitor for any signs of infection. During this time, researchers will check for any infections that occur within 30 days after the surgery. The study will also look at other outcomes, such as the need for additional surgery, any complications, and the length of hospital stay.

The trial is designed to be a fair test, meaning neither the participants nor the researchers will know which treatment each participant is receiving. This is known as a "double-blind" study. The purpose of the study is to find out if the new method of giving cefoxitin is better at preventing infections compared to the standard method. This information could help improve care for patients undergoing colorectal surgery in the future.

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 being an adult, undergoing colorectal surgery, and having provided informed consent.

  2. Step 2

    Pre-surgery preparation

    Before surgery, preparation involves understanding the procedure and the medications to be administered. The focus is on preventing surgical site infections.

  3. Step 3

    Medication administration

    Two types of medication are used: cefoxitin sodium and sodium chloride. Cefoxitin is administered intravenously as a solution for injection. Sodium chloride is used as a solution for infusion.

    The study compares two methods: intermittent administration of cefoxitin versus a loading dose followed by continuous infusion. The goal is to determine which method is more effective in preventing infections.

  4. Step 4

    Surgery

    The surgery is performed, with the duration expected to be more than 90 minutes. The focus is on minimizing the risk of infection during and after the procedure.

  5. Step 5

    Post-surgery monitoring

    After surgery, monitoring occurs for 30 days to check for any surgical site infections. The primary goal is to assess the proportion of patients with infections during this period.

  6. Step 6

    Evaluation of outcomes

    Secondary outcomes include evaluating the type of infections, any need for surgical reintervention, complications, and hospital readmissions. Other factors such as duration of hospital stay and any adverse events are also considered.

Who can join the trial?

5 criteria

  • Adult patients who are **18 years or older**.
  • Undergoing **colorectal surgery** that is expected to last more than **90 minutes**.
  • Patients who are part of a **Social Security system** or have access to it through someone else.
  • Individuals who are **free** and not under any legal guardianship or supervision.
  • Patients who have given their **informed consent**, meaning they understand the study and agree to participate.

Who cannot join the trial?

3 criteria

  • Patients who are not undergoing colorectal surgery cannot participate. Colorectal surgery is an operation on the colon or rectum.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection, like children or people with certain disabilities.
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Investigated drugs

Cefoxitin is an antibiotic used in this clinical trial to prevent infections at the site of surgery. The study is comparing two methods of administering this medication to see which is more effective in preventing infections after colorectal surgery. One method involves giving a loading dose followed by a continuous infusion, while the other method uses standard intermittent doses. The goal is to find out if the continuous infusion method is better at reducing infections within 30 days after surgery.

What is already known about the treatment

Cefoxitin – Cefoxitin is administered intravenously, either as intermittent doses or as a loading bolus followed by continuous infusion. It is currently being studied in clinical trials to determine its effectiveness in preventing surgical site infections after colorectal surgery. The main therapeutic indication for cefoxitin is to prevent infections during and after surgical procedures. At the molecular level, cefoxitin works by inhibiting bacterial cell wall synthesis, which leads to the death of the bacteria. It is classified as a second-generation cephalosporin antibiotic.

Investigated diseases

  • Surgical Site Infection (SSI)

    This condition occurs when bacteria infect the area of the body where surgery was performed. SSIs can be superficial, affecting only the skin, or more severe, involving tissues under the skin, organs, or implanted material. Symptoms may include redness, pain, and swelling at the surgical site, along with fever and drainage of cloudy fluid. The infection typically develops within 30 days after surgery. SSIs can lead to complications such as delayed healing and may require additional medical interventions. The risk of developing an SSI can vary based on the type of surgery and the patient's overall health.

  • Anastomotic Leak

    This condition occurs when there is a breakdown or failure at the surgical connection between two parts of the intestine. It can lead to the leakage of intestinal contents into the abdominal cavity, causing inflammation and infection. Symptoms may include abdominal pain, fever, and changes in bowel habits. The leak typically occurs within a few days to weeks after surgery. It can result in the need for further surgical intervention to repair the leak. The condition can complicate recovery and prolong hospital stays.

  • Clostridium difficile Infection

    This infection is caused by the bacterium Clostridium difficile, which can lead to inflammation of the colon. It often occurs after the use of antibiotics, which disrupt the normal balance of bacteria in the gut. Symptoms include diarrhea, abdominal pain, and fever. The infection can range from mild to severe and may lead to complications such as dehydration. It is commonly acquired in healthcare settings, particularly among patients receiving prolonged antibiotic treatment. The infection can be recurrent, requiring multiple treatments to resolve.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515146-16-00Protocol codePROPHYLOXITINEstimated enrolment2 000 patientsSponsorCentre Hospitalier Universitaire De Poitiers

sourced from the EU Clinical Trials Register and site verification

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