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

Conditions

• Anal Fistula
• Perianal Abscess

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Amoxicillin + Clavulanate — DRUG
  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.
• Ciprofloxacin + Metronidazole — DRUG
  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.

Study Details

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.

Key Dates

First listed

Jul 15, 2026

Start date

Aug 3, 2026

Status verified

Jun 2026

Primary completion

Feb 3, 2029

Completion

Aug 3, 2029

Study Design

Enrollment

236 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Antibiotics after Incision and Drainage
  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.
• No Intervention: No antibiotics after Incision and Drainage
  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.

Primary Outcome Measure

Number of participants who develop fistula in ano within 6 months after incision and drainage [ Time Frame: 6 months after incision and drainage ]

Central Contacts

• Mohamad A Abdulhai, MD
  3123554300
  [email protected]

Locations (1)

Find similar trials in Chicago, IL

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