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Could a simple antibiotic course after abscess drainage prevent future fistulas?

NCT ID NCT04549311

Disease control Sponsor: Sunnybrook Health Sciences Centre 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial looked at whether giving antibiotics after draining a perianal abscess can stop a painful fistula from forming. It involved 15 adults who had surgery for an abscess. Some got antibiotics, others did not. The main goal was to see if a larger study is even possible, not to prove the treatment works.

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 + clavulanic acid or ciprofloxacin + metronidazole)
What this could lead to
If it works, this could point toward a simple way to prevent painful fistulas after an abscess, reducing the need for more surgery.
What could go wrong
This is a very small vanguard trial with only 15 people, designed to test feasibility, not effectiveness. The evidence so far is low quality, so results may not be reliable.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

15 people

The number who actually took part.

Started

Nov 2021

Finished

Jan 2023

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: * Patients aged ≥18 years * Perianal abscess requiring incision and drainage Exclusion Criteria: * Allergies or contraindications to amoxicillin + clavulanic acid, penicillin, ciprofloxacin, or metronidazole * Definite need to be on antibiotics at the treating clinicians' discretion * Immunosuppression such as: human immunodeficiency virus (HIV), chronic steroids treatment, current chemotherapy * Abscess associated with Inflammatory Bowel Disease (IBD) * Supralevator perianal abscess * Recurrent perianal abscesses within 5 years * Known rectal cancer diagnosis within 5 years * History of pelvic radiotherapy within 5 years

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Conditions

The condition(s) this trial relates to.

anal fistula prevention target

As listed by the trial registrant

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

Perianal abscess Perianal fistula

Contacts and locations

Locations

  • North York General Hospital

    North York, Ontario, M2K 1E1, Canada

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6, Canada

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