Antibiotics After Incision and Drainage to Prevent Fistula Formation After First Episode of Perianal Abscess
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. 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.
Timeline
- Start
- 2026-08-03
- Primary completion
- 2029-02-03
- Completion
- 2029-08-03
Publications
- 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/bmjopen-2022-067970.
- Background 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/sur.2018.144. Epub 2018 Sep 20.
- Background Brook 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 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/s00384-023-04576-6.
- Background 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/acmi.0.000441. eCollection 2022.
- Background 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/DCR.0000000000002473. Epub 2022 Jul 5. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 875 mg | Oral |
| Subject | Ciprofloxacin | Small molecule | 500 mg | Oral |
| Subject | Clavulanate | Unknown | 125 mg | Oral |
| Subject | Metronidazole | Small molecule | 500 mg | Oral |