[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647131":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":19,"centralContacts":30,"locations":36,"responsibleParty":49,"collaborators":19,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":19,"enrollmentInfo":63,"targetDuration":19,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":82,"whyStopped":19,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University of Illinois at Chicago","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"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\u002Fclavulanate. Participants with penicillin allergy may receive ciprofloxacin plus metronidazole instead.",[13,14],"Drug: Amoxicillin + Clavulanate","Drug: Ciprofloxacin + Metronidazole",{"label":16,"type":17,"description":18,"interventionNames":19},"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.",null,[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":19},"DRUG","Amoxicillin + Clavulanate","Participants assigned to the antibiotics after incision and drainage arm will receive amoxicillin\u002Fclavulanate 875\u002F125 mg by mouth twice daily for 7 days after standard of care incision and drainage.",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":19},"Ciprofloxacin + Metronidazole","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.",[9],[31],{"name":32,"role":33,"phone":34,"phoneExt":19,"email":35},"Mohamad A Abdulhai, MD","CONTACT","3123554300","abdulhai@uic.edu",[37],{"facility":5,"status":19,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":19},"Chicago","Illinois","60612","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-87.65005,41.85003,{"lat":47,"lon":46},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Mohamad Abdulhai","Assistant Professor of Surgery","100647131","phase-4-antibiotics-after-incision-and-drainage-to-prevent-fistula-formation-after-first-episode-of-perianal-abscess-100647131",false,"NCT07704359","Antibiotics After Incision and Drainage to Prevent Fistula Formation After First Episode of Perianal Abscess","Randomized Antibiotics for Prevention of Fistula After Incision and Drainage of First-Episode Perianal Abscess (RAPID): A Randomized Controlled Trial","RAPID","Inclusion Criteria:\n\n* Age 18 years or older\n* First episode of perianal abscess requiring incision and drainage\n* Able to provide informed consent\n* English or Spanish speaking patient\n* Treating surgical team has determined that incision and drainage is clinically indicated as part of standard care\n\nExclusion Criteria:\n\n* Known fistula-in-ano at presentation\n* Prior perianal abscess within 12 months\n* History of inflammatory bowel disease, including Crohn's disease or ulcerative colitis\n* Known or suspected anorectal malignancy\n* Necrotizing soft tissue infection or Fournier's gangrene\n* Systemic infection or sepsis\n* Significant surrounding cellulitis or extensive soft-tissue infection for which antibiotics are clinically indicated\n* Immunocompromised or immunosuppressed status, including active chemotherapy or radiation therapy, history of transplant, chronic systemic steroids, biologic immunosuppressive therapy, advanced or uncontrolled HIV\u002FAIDS, or other clinically significant immunosuppression\n* Cardiac condition requiring antibiotic prophylaxis or antibiotic therapy for procedures involving infected tissue\n* Need for non-study antibiotics at the time of enrollment for another infection or medical indication\n* Contraindication, allergy, or intolerance to all study antibiotic regimens\n* Pregnant\n* Prisoner\n* Minor\n* Adult unable to provide informed consent","ALL","18 Years",{"count":64,"type":65},236,"ESTIMATED","INTERVENTIONAL",[68],"PHASE4","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.\n\nThe main questions it aims to answer are:\n\nDoes 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?\n\nResearchers 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.\n\nParticipants will:\n\nBe randomly assigned to recieve antibiotics for 7 days after abscess incision and drainage or to not recieve antibiotics after abscess incision and drainage.\n\nAttend follow-up clinic visits after incision and drainage as part of their standard of care.\n\nComplete 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.",[71,72],"Perianal Abscess","Anal Fistula",[74,75,76,77,78,79,80,81],"Perianal abscess","Anal fistula","Fistula-in-ano","Incision and Drainage","Antibiotics","Amixicillin clavulanate","Metronidazole","Ciprofloxacin","NOT_YET_RECRUITING","2026-07-09",{"date":85,"type":86},"2026-07-15","ACTUAL",{"date":88,"type":65},"2026-08-03",{"date":90,"type":65},"2029-08-03",{"name":5,"class":6},1]