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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago

About this trial

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.

Eligibility criteria

Qualifiers

Age 18 years or older

First episode of perianal abscess requiring incision and drainage

Able to provide informed consent

English or Spanish speaking patient

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Amoxicillin + Clavulanate
  • Ciprofloxacin + Metronidazole

Treatment groups

236 Participants
are divided into 2 treatment groups