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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Amoxicillin + Clavulanate
DrugParticipants 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
DrugParticipants 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.
Treatment groups
236 Participants
are divided into 2 treatment groupsGroup A: Antibiotics after Incision and DrainageExperimental treatment 2 interventions
Group B: No antibiotics after Incision and DrainageNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of participants who develop fistula in ano within 6 months after incision and drainage
Anal fistula formation will be assessed as a binary outcome for each participant. Fistula will be defined as documentation of a clinically diagnosed anal fistula during follow-up, based on clinical examination, imaging, operative or procedure findings, or medical record documentation.
Time frame
6 months after incision and drainageSecondary outcomes
1
Number of participants who develop Fistula in Ano within 12 months after incision and drainage
Anal fistula formation within 12 months will be assessed as a binary outcome for each participant. Participants will be counted as having developed a Fistula in Ano if a clinically diagnosed anal fistula is documented within 12 months after incision and drainage. Documentation may be based on clinical examination, imaging, operative or procedure findings, medical record review, or participant report during the 12-month follow-up phone call and confirmed by clinical documentation when available.
Time frame
12 months after incision and drainage2
Number of participants who develop recurrent perianal abscess within 12 months after incision and drainage.
Recurrent perianal abscess will be assessedas a binary outcome for each participant. Recurrent perianal abscess will be defined as documentation of a new or recurrent perianal abscess during follow-up, including clinical diagnosis, emergency department visit, clinic visit, imaging, or need for repeat drainage or procedure.
Time frame
12 months after incision and drainage3
Number of participants who require an additional abscess or fistula related procedure or intervention within 12 months after incision and drainage.
The need fo additional procedure or intervention will be assessed as a binary outcome for each participant. Participants will be counted as requiring an addictional procedure or intervention if any abscess or fistula related procedure is documented within 12 months after incision and drainage. Procedures may include repeat incision and drainage, examination under anesthesia, seton placement, fistulotomy, fistula repair, or other abscess or fistula related intervention documented in the medical record.
Time frame
12 months after incision and drainage4
Number of participants with an abscess or fistula emergency department visit or hospital readmission within 12 months after incision and drainage.
Emergency department visits or hospital readmissions will be assessed as a composite binary outcome for each participant. Participants will be counted in this outcome if they have at least one emergency department visit or at least one hospital readmission related to perianal abscess, fistula, wound infection, worsening symptoms, recurrent abscess, or complications of the assigned postoperative management strategy within 12 months after incision and drainage. Events will be identified through medical record review and follow-up assessments.
Time frame
12 months after incision and drainageSponsors and contacts
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Source ClinicalTrials.gov
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