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Antibiotics after abscess drainage may block painful fistula formation

NCT ID NCT07704359

Disease control Sponsor: University of Illinois at Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This trial tests whether a 7-day course of antibiotics after draining a first-time perianal abscess can stop an anal fistula from forming. Adults with a first abscess are randomly assigned to receive antibiotics or not, then followed for up to 12 months. The goal is to see if antibiotics lower the chance of developing this abnormal tunnel between the anal canal and skin.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
antibiotics (amoxicillin/clavulanate or ciprofloxacin plus metronidazole)
What this could lead to
If it works, this could become a standard way to prevent anal fistulas after a first abscess, reducing the need for further surgery.
What could go wrong
This is a single trial with 236 participants, so results may not apply to everyone. Antibiotics can cause side effects like diarrhea or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 236 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 years or older * First episode of perianal abscess requiring incision and drainage * Able to provide informed consent * English or Spanish speaking patient * Treating surgical team has determined that incision and drainage is clinically indicated as part of standard care Exclusion Criteria: * Known fistula-in-ano at presentation * Prior perianal abscess within 12 months * History of inflammatory bowel disease, including Crohn's disease or ulcerative colitis * Known or suspected anorectal malignancy * Necrotizing soft tissue infection or Fournier's gangrene * Systemic infection or sepsis * Significant surrounding cellulitis or extensive soft-tissue infection for which antibiotics are clinically indicated * Immunocompromised or immunosuppressed status, including active chemotherapy or radiation therapy, history of transplant, chronic systemic steroids, biologic immunosuppressive therapy, advanced or uncontrolled HIV/AIDS, or other clinically significant immunosuppression * Cardiac condition requiring antibiotic prophylaxis or antibiotic therapy for procedures involving infected tissue * Need for non-study antibiotics at the time of enrollment for another infection or medical indication * Contraindication, allergy, or intolerance to all study antibiotic regimens * Pregnant * Prisoner * Minor * Adult unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

Surgical Wound anal fistula prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anal fistula Perianal abscess

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Illinois at Chicago

    Chicago, Illinois, 60612, United States

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