drugset / Trial / NCT07704359

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

NCT07704359

Phase 4 Not yet recruiting 236 enrolled University of Illinois at Chicago
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2026-08-03
Primary completion
2029-02-03
Completion
2029-08-03

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 875 mg Oral
Subject Ciprofloxacin Small molecule 500 mg Oral
Subject Clavulanate Unknown 125 mg Oral
Subject Metronidazole Small molecule 500 mg Oral

Indications