Antibiotics for Perianal Abscess
(RAPID Trial)
What You Need to Know Before You Apply
What is the purpose of 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.
Are You a Good Fit for This Trial?
This trial is for adults who are having their first perianal abscess treated with incision and drainage. People who have had previous abscesses or fistulas, or certain other medical conditions, may not be eligible.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Amoxicillin + Clavulanate
- Ciprofloxacin + Metronidazole
Trial Overview
The study tests if taking antibiotics (either ciprofloxacin plus metronidazole, or amoxicillin plus clavulanate) for 7 days after surgical drainage of a perianal abscess can prevent the development of an anal fistula compared to not taking antibiotics. Participants are randomly assigned to receive antibiotics or no antibiotics.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants assigned to this arm will receive antibiotics for 7 days after standard of care incision and drainage of a first-time perianal abscess. The planned antibiotic regimen is amoxicillin/clavulanate. Participants with penicillin allergy may receive ciprofloxacin plus metronidazole instead.
Participants randomized to this arm will not receive postoperative antibiotics after standard of care incision and drainage, unless antibiotics are later determined to be clinically necessary by the treating clinician. Any antibiotic use after randomization will be recorded, and participants may continue study follow-up unless they withdraw or the study team determines that stopping participation is necessary for safety.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Illinois at Chicago
Lead Sponsor
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