[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07704359":3,"trial-entities:NCT07704359":144,"trial-summary:NCT07704359":148},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":48,"secondary_outcomes":53,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":15,"eligibility_criteria":74,"std_ages":98,"locations":101,"central_contacts":110,"overall_officials":116,"references":117,"see_also_links":137},"NCT07704359","STUDY2026-0396","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","NOT_YET_RECRUITING","2029-08-03","2026-06","2026-07-15","2026-08-03","University of Illinois at Chicago","OTHER",false,"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.","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.\n\nPerianal 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.\n\nEligible 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\u002Fclavulanate 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.\n\nAll 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.\n\nParticipants 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.",[19,20],"Perianal Abscess","Anal Fistula",[22,23,24,25,26,27,28,29],"Perianal abscess","Anal fistula","Fistula-in-ano","Incision and Drainage","Antibiotics","Amixicillin clavulanate","Metronidazole","Ciprofloxacin","INTERVENTIONAL","PREVENTION",[33],"PHASE4",{"count":35,"type":36},236,"ESTIMATED",[38,44],{"type":39,"name":40,"description":41,"armGroupLabels":42},"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.",[43],"Antibiotics after Incision and Drainage",{"type":39,"name":45,"description":46,"armGroupLabels":47},"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.",[43],[49],{"measure":50,"description":51,"timeFrame":52},"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.","6 months after incision and drainage",[54,58,61,64,67],{"measure":55,"description":56,"timeFrame":57},"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.","12 months after incision and drainage",{"measure":59,"description":60,"timeFrame":57},"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.",{"measure":62,"description":63,"timeFrame":57},"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.",{"measure":65,"description":66,"timeFrame":57},"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.",{"measure":68,"description":69,"timeFrame":70},"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.","Within 30 days after incision and drainage","ALL","18 Years",null,{"inclusion":75,"exclusion":81,"raw_text":97},[76,77,78,79,80],"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",[82,83,84,85,86,87,88,89,90,91,92,93,94,95,96],"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","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\u002FAIDS, 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","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",[99,100],"ADULT","OLDER_ADULT",[102],{"facility":13,"city":103,"state":104,"zip":105,"country":106,"geoPoint":107},"Chicago","Illinois","60612","United States",{"lat":108,"lon":109},41.85003,-87.65005,[111],{"name":112,"role":113,"phone":114,"email":115},"Mohamad A Abdulhai, MD","CONTACT","3123554300","abdulhai@uic.edu",[],[118,122,125,128,131,134],{"pmid":119,"type":120,"citation":121},"36351727","BACKGROUND","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\u002Fbmjopen-2022-067970.",{"pmid":123,"type":120,"citation":124},"30234438","Alabbad 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\u002Fsur.2018.144. Epub 2018 Sep 20.",{"pmid":126,"type":120,"citation":127},"9350771","Brook I, Frazier EH. The aerobic and anaerobic bacteriology of perirectal abscesses. J Clin Microbiol. 1997 Nov;35(11):2974-6. doi: 10.1128\u002Fjcm.35.11.2974-2976.1997.",{"pmid":129,"type":120,"citation":130},"38093036","Skovgaards 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\u002Fs00384-023-04576-6.",{"pmid":132,"type":120,"citation":133},"36415737","El 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\u002Facmi.0.000441. eCollection 2022.",{"pmid":135,"type":120,"citation":136},"35732009","Gaertner 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\u002FDCR.0000000000002473. Epub 2022 Jul 5. No abstract available.",[138,141],{"label":139,"url":140},"Specimen collection guidelines","https:\u002F\u002Fpathology.jhu.edu\u002Fbuild\u002Fassets\u002Fdepartment\u002Ffiles\u002FSpecimen-Collection-Guidelines-new.pdf",{"label":142,"url":143},"Characterization of Cryptoglandular Fistula Microbiome Using a Novel Technique","https:\u002F\u002Fctacs.org\u002Fwp-content\u002Fuploads\u002F2023\u002F10\u002FGeneral-and-Pediatric-Surgery-2023.pdf?utm_source",{"nct_id":4,"conditions":145,"biomarkers":147},[146,19],"Anorectal Fistula",[],{"nct_id":4,"found":149,"summary":150,"prompt_version":160},true,{"design":151,"status":152,"heading":153,"summary":154,"follow_up":155,"word_count":156,"commitments":157,"compensation":158,"drugs_mentioned":159},"This is a randomized, open-label study involving 236 participants. You would be randomly assigned to either receive antibiotics or no antibiotics after your surgery.","completed","Antibiotics for Perianal Abscess to Prevent Fistula Formation","This study is looking at whether taking antibiotics after surgery for a perianal abscess (a collection of infected fluid near the anus) can prevent an anal fistula (an abnormal tunnel) from forming. You might be eligible if you are 18 or older, have your first perianal abscess, and need surgery called incision and drainage. Participants will either receive antibiotics (Amoxicillin + Clavulanate, or Ciprofloxacin + Metronidazole if allergic to penicillin) for 7 days, or no antibiotics. The main goal is to see how many people develop a fistula within 6 months. The study status is unclear, and it plans to enroll 236 people.","Participants will be followed for 6 months after their incision and drainage procedure to see if a fistula develops.",103,"You would take antibiotics for 7 days if assigned to that group. The study will track whether you develop a fistula for 6 months after your surgery.","Not stated in the trial record.",[40,45],"v2"]