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Antibiotics for Perianal Abscess to Prevent Fistula Formation

This study is looking at whether taking antibiotics after surgery for a perianal abscess (a collection of infected fluid near the anus) can prevent an anal fistula (an abnormal tunnel) from forming. You might be eligible if you are 18 or older, have your first perianal abscess, and need surgery called incision and drainage. Participants will either receive antibiotics (Amoxicillin + Clavulanate, or Ciprofloxacin + Metronidazole if allergic to penicillin) for 7 days, or no antibiotics. The main goal is to see how many people develop a fistula within 6 months. The study status is unclear, and it plans to enroll 236 people.

Study design
This is a randomized, open-label study involving 236 participants. You would be randomly assigned to either receive antibiotics or no antibiotics after your surgery.
What's involved
You would take antibiotics for 7 days if assigned to that group. The study will track whether you develop a fistula for 6 months after your surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after their incision and drainage procedure to see if a fistula develops.

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NCT07704359

Antibiotics After Incision and Drainage to Prevent Fistula Formation After First Episode of Perianal Abscess

Not Yet Recruiting
PHASE4Ages 18+InterventionalPrevention
University of Illinois at Chicago
~236 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Amoxicillin + ClavulanateCiprofloxacin + Metronidazole

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants who develop fistula in ano within 6 months after incision and drainage
Measured over 6 months after incision and drainage

Conditions

Perianal Abscess
Anal Fistula

Explore related trials

Anorectal FistulaPerianal Abscess

Where it's being run

1 sites across 1 states
Illinois1

Who to contact

Mohamad A Abdulhai, MD
[email protected]
3123554300
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of participants who develop fistula in ano within 6 months after incision and drainage6 months after incision and drainage

    Anal fistula formation will be assessed as a binary outcome for each participant. Fistula will be defined as documentation of a clinically diagnosed anal fistula during follow-up, based on clinical examination, imaging, operative or procedure findings, or medical record documentation.