Perianal AbscessPhase 4RAPIDNCT07704359
Antibiotics After Incision and Drainage to Prevent Fistula Formation After First Episode of Perianal Abscess
A Phase 4 study testing Amoxicillin + Clavulanate and Ciprofloxacin + Metronidazole in people with Perianal Abscess and Anal Fistula, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Abscess, Anal Fistula
- What is being tested?
- Amoxicillin + Clavulanate and Ciprofloxacin + Metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2026to 3 Aug 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- First episode of perianal abscess requiring incision and drainage
- Able to provide informed consent
- English or Spanish speaking patient
- Treating surgical team has determined that incision and drainage is clinically indicated as part of standard care
Who cannot join
- 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
- Necrotizing soft tissue infection or Fournier's gangrene
- Systemic infection or sepsis
Show all 15Show fewer
- Significant surrounding cellulitis or extensive soft-tissue infection for which antibiotics are clinically indicated
- Immunocompromised or immunosuppressed status, including active chemotherapy or radiation therapy, history of transplant, chronic systemic steroids, biologic immunosuppressive therapy, advanced or uncontrolled HIV/AIDS, or other clinically significant immunosuppression
- Cardiac condition requiring antibiotic prophylaxis or antibiotic therapy for procedures involving infected tissue
- Need for non-study antibiotics at the time of enrollment for another infection or medical indication
- Contraindication, allergy, or intolerance to all study antibiotic regimens
- Pregnant
- Prisoner
- Minor
- Adult unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Randomized Antibiotics for Prevention of Fistula After Incision and Drainage of First-Episode Perianal Abscess (RAPID): A Randomized Controlled 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:
Read more
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.
Read the detailed description
This is a single-center, randomized, open-label clinical trial evaluating whether a 7-day course of postoperative antibiotics after standard of care incision and drainage of a first-time perianal abscess reduces subsequent anal fistula formation compared with no postoperative antibiotics.
Perianal abscess is a common anorectal condition treated primarily with incision and drainage. After drainage, some patients later develop an anal fistula, which is an abnormal tract between the anal canal and the perianal skin. The role of routine antibiotics after adequate drainage remains uncertain, especially in patients without high-risk clinical features that would otherwise require antibiotics as part of standard care. This study is designed to evaluate whether a short postoperative antibiotic course can reduce fistula formation after a first episode of perianal abscess.
Eligible adult participants with a first-time perianal abscess requiring incision and drainage will be randomized in a 1:1 ratio to either postoperative antibiotics or no postoperative antibiotics. Participants assigned to the antibiotic arm will receive amoxicillin/clavulanate for 7 days. Participants with penicillin allergy may receive ciprofloxacin plus metronidazole instead. Participants assigned to the no-antibiotic arm will not receive postoperative antibiotics unless antibiotics are later determined to be medically necessary by the treating clinician.
All participants will receive standard clinical care for the perianal abscess, including incision and drainage as determined by the treating surgical team. The study does not change the technical approach to drainage or other clinically indicated care. The research intervention is the randomized postoperative antibiotic strategy.
Participants will be followed through routine clinical visits and a 12-month follow-up phone call. The study will collect information from the medical record and follow-up contacts regarding fistula formation, recurrent abscess, additional procedures or treatment, emergency department visits or readmissions, antibiotic use, medication adherence, and antibiotic-related adverse events. The findings may help clarify whether routine postoperative antibiotics should be used after drainage of first-time perianal abscess in patients without other clinical indications for antibiotics.
- Conditions
- Perianal Abscess, Anal Fistula
- Being tested
- Amoxicillin + Clavulanate, Ciprofloxacin + Metronidazole
- Keywords
- Perianal abscess, Anal fistula, Fistula-in-ano, Incision and Drainage, Antibiotics, Amixicillin clavulanate, Metronidazole, Ciprofloxacin
- Medical subject headings
- Rectal Fistula, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin + ClavulanateDrug
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 + MetronidazoleDrug
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 group | Role | What they receive |
|---|---|---|
| Antibiotics after Incision and Drainage | Experimental | 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. Receives: Drug: Amoxicillin + Clavulanate; Drug: Ciprofloxacin + Metronidazole |
| No antibiotics after Incision and Drainage | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after incision and drainage
Secondary outcomes (5)
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.
Measured: 12 months after incision and drainage
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.
Measured: 12 months after incision and drainage
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.
Measured: 12 months after incision and drainage
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.
Measured: 12 months after incision and drainage
Number of participants with antibiotic adverse events by event type within 30 days after incision and drainage.
Antibiotic adverse events will include medication side effects or complications, documented during follow-up or through medical record review. These include nausea, vomiting, diarrhea, rash, allergic reaction, yeast infection, clostridioides difficile infection, tendon symptoms, neurologic symptoms, liver-related symptoms, or other adverse events attributed to antibiotic therapy. Adverse event will be summarized by event type. The number of participants with each adverse event type will be reported. A participant may be counted in more than one adverse event type if multiple events occur.
Measured: Within 30 days after incision and drainage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start5 Oct 2026 (estimated)
- Primary completion3 Feb 2029 (estimated)
- Study completion3 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Perianal AbscessStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to postoperative antibiotics or no postoperative antibiotics after standard of care incision and drainage of a first-episode perianal abscess.
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704359
- Sponsor's protocol ID
- STUDY2026-0396
- Acronym
- RAPID
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available. Aggregate study results will be reported as required and may be published in scientific presentations or manuscripts.
Publications
van Oostendorp JY, Dekker L, van Dieren S, Bemelman WA, Han-Geurts IJM. Antibiotic Treatment foLlowing surgical drAinage of perianal abScess (ATLAS): protocol for a multicentre, double-blind, placebo-controlled, randomised trial. BMJ Open. 2022 Nov 8;12(11):e067970. doi: 10.1136/bmjopen-2022-067970.
PubMed 36351727Alabbad J, Abdul Raheem F, Alkhalifa F, Hassan Y, Al-Banoun A, Alfouzan W. Retrospective Clinical and Microbiologic Analysis of Patients with Anorectal Abscess. Surg Infect (Larchmt). 2019 Jan;20(1):31-34. doi: 10.1089/sur.2018.144. Epub 2018 Sep 20.
PubMed 30234438Brook I, Frazier EH. The aerobic and anaerobic bacteriology of perirectal abscesses. J Clin Microbiol. 1997 Nov;35(11):2974-6. doi: 10.1128/jcm.35.11.2974-2976.1997.
PubMed 9350771Skovgaards DM, Perregaard H, Dibbern CB, Nordholm-Carstensen A. Fistula development after anal abscess drainage-a multicentre retrospective cohort study. Int J Colorectal Dis. 2023 Dec 13;39(1):4. doi: 10.1007/s00384-023-04576-6.
PubMed 38093036El Boghdady M, Ewalds-Kvist BM, Zhao S, Najdawi A, Laliotis A. Post-operative antibiotics for cutaneous abscess after incision and drainage: Variations in clinical practice. Access Microbiol. 2022 Oct 28;4(10):acmi000441. doi: 10.1099/acmi.0.000441. eCollection 2022.
PubMed 36415737Gaertner WB, Burgess PL, Davids JS, Lightner AL, Shogan BD, Sun MY, Steele SR, Paquette IM, Feingold DL; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Anorectal Abscess, Fistula-in-Ano, and Rectovaginal Fistula. Dis Colon Rectum. 2022 Aug 1;65(8):964-985. doi: 10.1097/DCR.0000000000002473. Epub 2022 Jul 5. No abstract available.
PubMed 35732009
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Antibiotics for Prevention of Fistula After Incision and Drainage of First-Episode Perianal Abscess (RAPID): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07704359
- Acronym / sponsor ID
- RAPID / STUDY2026-0396
- Conditions
- Perianal Abscess, Anal Fistula
- Keywords
- Perianal abscess, Anal fistula, Fistula-in-ano, Incision and Drainage, Antibiotics, Amixicillin clavulanate, Metronidazole, Ciprofloxacin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 3 Feb 2029 (estimated)
- Study completion
- 3 Aug 2029 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-center, randomized, open-label clinical trial evaluating whether a 7-day course of postoperative antibiotics after standard of care incision and drainage of a first-time perianal abscess reduces subsequent anal fistula formation compared with no postoperative antibiotics.
Perianal abscess is a common anorectal condition treated primarily with incision and drainage. After drainage, some patients later develop an anal fistula, which is an abnormal tract between the anal canal and the perianal skin. The role of routine antibiotics after adequate drainage remains uncertain, especially in patients without high-risk clinical features that would otherwise require antibiotics as part of standard care. This study is designed to evaluate whether a short postoperative antibiotic course can reduce fistula formation after a first episode of perianal abscess.
Eligible adult participants with a first-time perianal abscess requiring incision and drainage will be randomized in a 1:1 ratio to either postoperative antibiotics or no postoperative antibiotics. Participants assigned to the antibiotic arm will receive amoxicillin/clavulanate for 7 days. Participants with penicillin allergy may receive ciprofloxacin plus metronidazole instead. Participants assigned to the no-antibiotic arm will not receive postoperative antibiotics unless antibiotics are later determined to be medically necessary by the treating clinician.
All participants will receive standard clinical care for the perianal abscess, including incision and drainage as determined by the treating surgical team. The study does not change the technical approach to drainage or other clinically indicated care. The research intervention is the randomized postoperative antibiotic strategy.
Participants will be followed through routine clinical visits and a 12-month follow-up phone call. The study will collect information from the medical record and follow-up contacts regarding fistula formation, recurrent abscess, additional procedures or treatment, emergency department visits or readmissions, antibiotic use, medication adherence, and antibiotic-related adverse events. The findings may help clarify whether routine postoperative antibiotics should be used after drainage of first-time perianal abscess in patients without other clinical indications for antibiotics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to postoperative antibiotics or no postoperative antibiotics after standard of care incision and drainage of a first-episode perianal abscess.
| Arm | Type | Receives |
|---|---|---|
| Antibiotics after Incision and Drainage | Experimental | Drug: Amoxicillin + Clavulanate, Drug: Ciprofloxacin + MetronidazoleParticipants 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 antibiotics after Incision and Drainage | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- First episode of perianal abscess requiring incision and drainage
- Able to provide informed consent
- English or Spanish speaking patient
- Treating surgical team has determined that incision and drainage is clinically indicated as part of standard care
Key exclusion criteria (15 listed)
- 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
- Necrotizing soft tissue infection or Fournier's gangrene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin + ClavulanateParticipants 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. | Drug | Antibiotics after Incision and Drainage |
| Ciprofloxacin + MetronidazoleParticipants 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. | Drug | Antibiotics after Incision and Drainage |
Primary outcome
Number of participants who develop fistula in ano within 6 months after incision and drainage
Time frame: 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.
5 secondary outcomes
Number of participants who develop Fistula in Ano within 12 months after incision and drainage
Time frame: 12 months after incision and drainage
Number of participants who develop recurrent perianal abscess within 12 months after incision and drainage.
Time frame: 12 months after incision and drainage
Number of participants who require an additional abscess or fistula related procedure or intervention within 12 months after incision and drainage.
Time frame: 12 months after incision and drainage
Number of participants with an abscess or fistula emergency department visit or hospital readmission within 12 months after incision and drainage.
Time frame: 12 months after incision and drainage
Number of participants with antibiotic adverse events by event type within 30 days after incision and drainage.
Time frame: Within 30 days after incision and drainage
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 36351727van Oostendorp JY, Dekker L, van Dieren S, Bemelman WA, Han-Geurts IJM. Antibiotic Treatment foLlowing surgical drAinage of perianal abScess (ATLAS): protocol for a multicentre, double-blind, placebo-controlled, randomised trial. BMJ Open. 2022 Nov 8;12(11):e067970. doi: 10.1136/bmjopen-2022-067970.
- Background: PubMed 30234438Alabbad J, Abdul Raheem F, Alkhalifa F, Hassan Y, Al-Banoun A, Alfouzan W. Retrospective Clinical and Microbiologic Analysis of Patients with Anorectal Abscess. Surg Infect (Larchmt). 2019 Jan;20(1):31-34. doi: 10.1089/sur.2018.144. Epub 2018 Sep 20.
- Background: PubMed 9350771Brook I, Frazier EH. The aerobic and anaerobic bacteriology of perirectal abscesses. J Clin Microbiol. 1997 Nov;35(11):2974-6. doi: 10.1128/jcm.35.11.2974-2976.1997.
- Background: PubMed 38093036Skovgaards DM, Perregaard H, Dibbern CB, Nordholm-Carstensen A. Fistula development after anal abscess drainage-a multicentre retrospective cohort study. Int J Colorectal Dis. 2023 Dec 13;39(1):4. doi: 10.1007/s00384-023-04576-6.
- Background: PubMed 36415737El Boghdady M, Ewalds-Kvist BM, Zhao S, Najdawi A, Laliotis A. Post-operative antibiotics for cutaneous abscess after incision and drainage: Variations in clinical practice. Access Microbiol. 2022 Oct 28;4(10):acmi000441. doi: 10.1099/acmi.0.000441. eCollection 2022.
- Background: PubMed 35732009Gaertner WB, Burgess PL, Davids JS, Lightner AL, Shogan BD, Sun MY, Steele SR, Paquette IM, Feingold DL; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Anorectal Abscess, Fistula-in-Ano, and Rectovaginal Fistula. Dis Colon Rectum. 2022 Aug 1;65(8):964-985. doi: 10.1097/DCR.0000000000002473. Epub 2022 Jul 5. No abstract available.
- Specimen collection guidelinesLink provided by the sponsor.
- Characterization of Cryptoglandular Fistula Microbiome Using a Novel TechniqueLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available. Aggregate study results will be reported as required and may be published in scientific presentations or manuscripts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin + Clavulanate and Ciprofloxacin + Metronidazole in people with Perianal Abscess and Anal Fistula, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamad A Abdulhai, MD (3123554300, abdulhai@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07704359, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.