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

NCT07704359 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2026-07-15

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if antibiotics can prevent the formation of fistula-in-ano after incision and drainage of a first time of perianal abscess in adults. A perianal abscess is a collection of infected fluid near the anus. A Fistula-in-ano is an abnormal tunnel that can form between the anal canal and the skin after an abscess.

The main questions it aims to answer are:

Does taking antibiotics after incision and drainage of a perianal abscess lower the chance of developing a Fistula-in-ano? What medical problems or side effects do participants have after taking antibiotics or not taking antibiotics?

Researchers will compare participants who recieve antibiotics after abscess drainage with paticipants who do not recieve antibiotics after abscess drainage, to see if antibiotics lower the chance of developing a Fistula-in-ano.

Participants will:

Be randomly assigned to recieve antibiotics for 7 days after abscess incision and drainage or to not recieve antibiotics after abscess incision and drainage.

Attend follow-up clinic visits after incision and drainage as part of their standard of care.

Complete follow-up phone call about 12 months after incision and drainage. Allow the study team to review their medical record for abscess treatment, symptoms, recurrence, fistula-in-ano formation, additional procedures, and antibiotics side effects.

Conditions

  • Perianal Abscess
  • Anal Fistula

Interventions

DRUG

Amoxicillin + Clavulanate

Participants assigned to the antibiotics after incision and drainage arm will receive amoxicillin/clavulanate 875/125 mg by mouth twice daily for 7 days after standard of care incision and drainage.

DRUG

Ciprofloxacin + Metronidazole

Participants assigned to the antibiotics after incision and drainage arm who have a penicillin allergy may receive ciprofloxacin 500 mg by mouth twice daily plus metronidazole 500 mg by mouth three times daily for 7 days after standard of care incision and drainage.

Sponsors & Collaborators

  • University of Illinois at Chicago

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-03
Primary Completion
2029-02-03
Completion
2029-08-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07704359 on ClinicalTrials.gov