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Study on Amoxicillin and Potassium Clavulanate for Preventing Anal Fistula in Patients After First Perianal Abscess Surgery

Verified siteRegistered 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 studying the effectiveness of a treatment involving amoxicillin/clavulanic acid for patients who have undergone surgery for their first episode of a perianal abscess. A perianal abscess is a painful condition where a collection of pus forms near the anus. The treatment aims to prevent the development of an anal fistula, which is an abnormal connection that can form between the end of the bowel and the skin near the anus after an abscess.

The purpose of the study is to determine if taking the antibiotic combination of amoxicillin trihydrate and potassium clavulanate after surgical drainage of the abscess can effectively prevent the formation of an anal fistula. Participants in the study will be randomly assigned to receive either the medication or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, ensuring unbiased results.

Throughout the study, participants will be monitored for the development of an anal fistula and other related outcomes, such as the time it takes for a fistula to appear, the complexity of any fistula that does develop, and the need for further surgery. The study will also assess the quality of life of participants using a specific questionnaire. The trial is expected to continue until the end of 2027, with the goal of providing valuable insights into the prevention of anal fistulas following a perianal abscess.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after undergoing surgery for the first episode of a perianal abscess.

    Eligibility includes being at least 18 years old, having the ability to eat normally, and agreeing to follow the study procedures.

    A signed informed consent form is required before any study-related activities.

  2. Step 2

    Medication administration

    The medication used in the study is a combination of amoxicillin trihydrate and potassium clavulanate.

    This medication is provided in the form of a film-coated tablet.

    The dosage is 875 mg of amoxicillin and 125 mg of clavulanic acid per tablet.

    The medication is taken orally.

  3. Step 3

    Monitoring and follow-up

    The main goal is to assess the effectiveness of the antibiotic in preventing the development of an anal fistula after surgery.

    Regular follow-up visits are scheduled to monitor health and any development of a fistula.

    The study will track the percentage of participants who develop a fistula, the time it takes for a fistula to appear, and the complexity of any fistula that develops.

    Additional assessments include checking for new episodes of perianal abscess and the need for further surgery.

    Quality of life is evaluated using a specific questionnaire after any fistula development.

  4. Step 4

    Study duration

    The study is expected to continue until December 31, 2027.

    Participants will be involved in the study from the time of recruitment, which began on March 1, 2022.

Who can join the trial?

5 criteria

  • Must be a male or female adult who is at least 18 years old.
  • Must have had surgery for their first episode of a perianal abscess. A perianal abscess is a painful, swollen area near the anus filled with pus.
  • Must be able to eat normally by mouth, known as oral feeding.
  • Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests and other study procedures.
  • Must sign a written informed consent form before any study procedures begin. This means they agree to participate in the study after being informed about it.

Who cannot join the trial?

1 criterion

  • Patients who have had surgery for their first episode of a perianal abscess. A perianal abscess is a painful, swollen area near the anus filled with pus.
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Investigated drugs

Amoxicillin/Clavulanic Acid is an antibiotic used in this clinical trial to prevent the development of anal fistula after surgical drainage of a perianal abscess. It works by stopping the growth of bacteria that can cause infections, helping to reduce the risk of complications following surgery.

What is already known about the treatment

Amoxicillin/Clavulanic Acid – This medication is administered orally in the form of tablets or liquid suspension. It is currently well-established in medical practice and literature as a combination antibiotic used to treat various bacterial infections. The main therapeutic indication in this trial is to prevent the development of anal fistula following surgical drainage of a perianal abscess. At the molecular level, amoxicillin works by inhibiting bacterial cell wall synthesis, while clavulanic acid inhibits beta-lactamase enzymes produced by bacteria, enhancing the effectiveness of amoxicillin. It is classified pharmacologically as a penicillin antibiotic combined with a beta-lactamase inhibitor.

Investigated diseases

  • Perianal Abscess

    A perianal abscess is a painful condition characterized by a collection of pus near the anus. It often results from an infection of the small anal glands. The abscess can cause swelling, redness, and tenderness in the affected area. If not properly managed, it may lead to the formation of a perianal fistula, which is an abnormal connection between the anal canal and the skin. Surgical drainage is typically required to relieve the abscess and prevent further complications. The condition can recur if the underlying infection is not fully resolved.

  • Perianal Fistula

    A perianal fistula is an abnormal tunnel that forms between the anal canal and the skin near the anus. It often develops as a result of a previous perianal abscess that did not heal completely. The fistula can cause persistent drainage, discomfort, and irritation around the anus. It may also lead to recurrent infections and abscesses if not addressed. The complexity of the fistula can vary, affecting the ease of treatment. Surgical intervention is often necessary to close the fistula and prevent further issues.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520193-35-00Protocol codePERIQxAEstimated enrolment300 patientsSponsorMARIANO ARTES CASELLES

sourced from the EU Clinical Trials Register and site verification

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