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Antibiotics After Incision and Drainage to Prevent Fistula Formation After First Episode of Perianal Abscess (RAPID)

2026年7月9日 更新者:Mohamad Abdulhai、University of Illinois at Chicago

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:

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

236

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Mohamad A Abdulhai, MD
  • 电话号码:3123554300
  • 邮箱:abdulhai@uic.edu

学习地点

    • Illinois
      • Chicago、Illinois、美国、60612
        • University of Illinois at Chicago

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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/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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Antibiotics after Incision and Drainage
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.
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.
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.
无干预:No antibiotics after Incision and Drainage
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of participants who develop fistula in ano within 6 months after incision and drainage
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Number of participants who develop Fistula in Ano within 12 months after incision and drainage
大体时间: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
Number of participants who develop recurrent perianal abscess within 12 months after incision and drainage.
大体时间: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.
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.
大体时间: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.
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.
大体时间: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.
12 months after incision and drainage
Number of participants with antibiotic adverse events by event type within 30 days after incision and drainage.
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月3日

初级完成 (估计的)

2029年2月3日

研究完成 (估计的)

2029年8月3日

研究注册日期

首次提交

2026年7月2日

首先提交符合 QC 标准的

2026年7月9日

首次发布 (实际的)

2026年7月15日

研究记录更新

最后更新发布 (实际的)

2026年7月15日

上次提交的符合 QC 标准的更新

2026年7月9日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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