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NOT YET RECRUITING
NCT07704359
PHASE4

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

Sponsor: University of Illinois at Chicago

View on ClinicalTrials.gov

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.

Official title: Randomized Antibiotics for Prevention of Fistula After Incision and Drainage of First-Episode Perianal Abscess (RAPID): A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

236

Start Date

2026-08-03

Completion Date

2029-08-03

Last Updated

2026-07-15

Healthy Volunteers

No

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.

Locations (1)

University of Illinois at Chicago

Chicago, Illinois, United States