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Perianal Abscess Recurrence and Fistula Formation: Antibiotics Following Incision and Drainage Trial (PARFAIT)

Primary Purpose

Perianal Abscess, Perianal Fistula

Status
Active
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Antibiotic 1 arm (amoxicillin + clavulanic acid)
Antibiotic 2 arm (ciprofloxacin + metronidazole)
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perianal Abscess focused on measuring Post-operative antibiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged ≥18 years
  • Perianal abscess requiring incision and drainage

Exclusion Criteria:

  • Allergies or contraindications to amoxicillin + clavulanic acid, penicillin, ciprofloxacin, or metronidazole
  • Definite need to be on antibiotics at the treating clinicians' discretion
  • Immunosuppression such as: human immunodeficiency virus (HIV), chronic steroids treatment, current chemotherapy
  • Abscess associated with Inflammatory Bowel Disease (IBD)
  • Supralevator perianal abscess
  • Recurrent perianal abscesses within 5 years
  • Known rectal cancer diagnosis within 5 years
  • History of pelvic radiotherapy within 5 years

Sites / Locations

  • North York General Hospital
  • The Ottawa Hospital
  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Antibiotic 1 arm (amoxicillin + clavulanic acid)

Antibiotic 2 arm (ciprofloxacin + metronidazole)

No antibiotics

Arm Description

Patients will undergo I&D of PA by the clinician as per standard of care. This may occur in the emergency department or operating room. Patients may or may not receive packing based on the clinician's standard practice and institutional routines. Patients randomized to the antibiotic 1 arm will receive a prescription for amoxicillin + clavulanic acid (875 mg amoxicillin and 125 mg clavulanic acid BID) PO for 7 days. Otherwise, all participants will be treated identically according to the institution's standard practices.

Patients will undergo I&D of PA by the clinician as per standard of care. This may occur in the emergency department or operating room. Patients may or may not receive packing based on the clinician's standard practice and institutional routines. Patients randomized to the antibiotic 2 arm will receive a prescription for ciprofloxacin + metronidazole (ciprofloxacin 500 mg and metronidazole 500 mg BID) PO for 7 days. Otherwise, all participants will be treated identically according to the institution's standard practices.

Patients will undergo I&D of PA by the clinician as per standard of care. This may occur in the emergency department or operating room. Patients may or may not receive packing based on the clinician's standard practice and institutional routines. In the comparator arm, patients will not receive any antibiotics. Otherwise, all participants will be treated identically according to the institution's standard practices.

Outcomes

Primary Outcome Measures

Total number of participants accrued across all sites, per month
Feasible if 3 or more patients accrued per month between all sites
Proportion of participants who received the allocated intervention, across all sites
Feasible if >90% of patients receive correct intervention
Proportion of complete data collection for patient-reported outcome surveys, across all sites
Feasible if >80% of data is collected
Proportion of successful data linkage of patient-reported outcome data with Institute of Clinical Evaluative Sciences dataset(s)
Feasible if linkage is possible in >90% of patients
Estimation of fistula formation in three groups
Rate of fistula formation in the three groups

Secondary Outcome Measures

Full Information

First Posted
September 8, 2020
Last Updated
October 5, 2023
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04549311
Brief Title
Perianal Abscess Recurrence and Fistula Formation: Antibiotics Following Incision and Drainage Trial
Acronym
PARFAIT
Official Title
Perianal Abscess Recurrence and Fistula Formation: Antibiotics Following Incision and Drainage Trial - (PARFAIT) A Vanguard Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Most perianal abscesses (PA) result from an infection originating in anal crypts that extend into anal glands in the intersphincteric plane. Patients commonly present to the ER and usually require surgical intervention, which poses a burden on the healthcare system. If left undrained, a PA can expand into the adjacent tissues as well as progress to systemic infection. One of the major complications of PA are perianal fistulae; the creation of a tract between the anal canal and the perianal skin that is lined with granulation tissue or skin cells. Up to 1/3 of patients with a PA will develop a fistula; which occurs if a PA drains spontaneously through the perianal skin, and the infection becomes chronic. If this happens, surgical intervention is needed and abscesses may reoccur. Post incision and drainage (I&D) antibiotics in PA have been used to address complications but their use is still controversial and there are no specific recommendations on their use to prevent the formations of fistulae. Recent findings from a systematic review (6 studies, N=817 patients) published in 2019 demonstrated that antibiotic use following I&D of PA was associated with a 36% lower odds of fistula formation, though the quality of the evidence was low. As there are no established prophylactic treatments for fistulae, and because they are difficult to treat, further study of this simple intervention seems warranted. In this trial, adults with a PA requiring I&D will be randomly assigned to receive standard of care with antibiotics or standard of care without antibiotics after I&D. This trial will be conducted under the IMPACTS (Innovative, Multicentre, Patient-centred Approach to Clinical Trials in Surgery) program umbrella and will follow IMPACTS methodology. For the Vanguard trial, the aim is to determine the feasibility of conducting a definitive trial. Future outcomes of interest are incidence of fistula formation (defined as drainage of the perianal region at or after 2 months), need for re-intervention (i.e., any intervention on the perianal region), quality of life, healthcare utilization, healing time and mortality.
Detailed Description
The development of perianal abscesses is relatively common with an estimated incidence in the UK of 40 per 100,000 habitants (Canadian incidence unknown). It is uncertain if there is any benefit to using prophylactic antibiotics after incision and drainage of a perianal abscess in order to reduce the formation of fistulae, the need for re-intervention, health system costs, and healing time. Further research from high-quality RCTs is needed to establish a benefit, if any, for this practice. Objectives: Before embarking on a definitive RCT, this pilot trial has five specific feasibility objectives: To assess our ability to accrue patients using the IMPACTS Program design platform at multiple institutions, over the course of one year. To assess our ability to adaptively randomize patients and deliver the randomized assignment using the IMPACTS Program design platform, over the course of one year. To assess our ability to collect complete data directly from participants (patients and clinicians) on: re-intervention, fistula formation, quality of life, and healing time over the course of one year. To examine our ability to carry out data linkages using the IMPACTS Program design platform over the course of one year. To estimate the incidence of fistula formation to inform the sample size calculation for the definitive trial. Study design: This is a multicentre, pragmatic, open label, three-arm parallel-group Vanguard feasibility randomized controlled trial. Adult patients with perianal abscesses requiring incision and drainage will be randomized to receive standard of care with antibiotics or standard of care without antibiotics after incision and drainage. If feasibility is demonstrated during the pilot trial, we will plan to conduct a definitive trial. If there are only minimal changes to the protocol, we will include data from the pilot phase into the definitive trial analysis (i.e. a Vanguard design).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perianal Abscess, Perianal Fistula
Keywords
Post-operative antibiotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Pragmatic, multicenter, open-label, three-arm parallel-group Vanguard feasibility randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antibiotic 1 arm (amoxicillin + clavulanic acid)
Arm Type
Active Comparator
Arm Description
Patients will undergo I&D of PA by the clinician as per standard of care. This may occur in the emergency department or operating room. Patients may or may not receive packing based on the clinician's standard practice and institutional routines. Patients randomized to the antibiotic 1 arm will receive a prescription for amoxicillin + clavulanic acid (875 mg amoxicillin and 125 mg clavulanic acid BID) PO for 7 days. Otherwise, all participants will be treated identically according to the institution's standard practices.
Arm Title
Antibiotic 2 arm (ciprofloxacin + metronidazole)
Arm Type
Active Comparator
Arm Description
Patients will undergo I&D of PA by the clinician as per standard of care. This may occur in the emergency department or operating room. Patients may or may not receive packing based on the clinician's standard practice and institutional routines. Patients randomized to the antibiotic 2 arm will receive a prescription for ciprofloxacin + metronidazole (ciprofloxacin 500 mg and metronidazole 500 mg BID) PO for 7 days. Otherwise, all participants will be treated identically according to the institution's standard practices.
Arm Title
No antibiotics
Arm Type
No Intervention
Arm Description
Patients will undergo I&D of PA by the clinician as per standard of care. This may occur in the emergency department or operating room. Patients may or may not receive packing based on the clinician's standard practice and institutional routines. In the comparator arm, patients will not receive any antibiotics. Otherwise, all participants will be treated identically according to the institution's standard practices.
Intervention Type
Drug
Intervention Name(s)
Antibiotic 1 arm (amoxicillin + clavulanic acid)
Intervention Description
Prescription of antibiotics (amoxicillin + clavulanic acid) after incision and drainage of perianal abscess.
Intervention Type
Drug
Intervention Name(s)
Antibiotic 2 arm (ciprofloxacin + metronidazole)
Intervention Description
Prescription of antibiotics (ciprofloxacin + metronidazole) after incision and drainage of perianal abscess.
Primary Outcome Measure Information:
Title
Total number of participants accrued across all sites, per month
Description
Feasible if 3 or more patients accrued per month between all sites
Time Frame
1 year
Title
Proportion of participants who received the allocated intervention, across all sites
Description
Feasible if >90% of patients receive correct intervention
Time Frame
1 year
Title
Proportion of complete data collection for patient-reported outcome surveys, across all sites
Description
Feasible if >80% of data is collected
Time Frame
1 year
Title
Proportion of successful data linkage of patient-reported outcome data with Institute of Clinical Evaluative Sciences dataset(s)
Description
Feasible if linkage is possible in >90% of patients
Time Frame
1 year
Title
Estimation of fistula formation in three groups
Description
Rate of fistula formation in the three groups
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged ≥18 years Perianal abscess requiring incision and drainage Exclusion Criteria: Allergies or contraindications to amoxicillin + clavulanic acid, penicillin, ciprofloxacin, or metronidazole Definite need to be on antibiotics at the treating clinicians' discretion Immunosuppression such as: human immunodeficiency virus (HIV), chronic steroids treatment, current chemotherapy Abscess associated with Inflammatory Bowel Disease (IBD) Supralevator perianal abscess Recurrent perianal abscesses within 5 years Known rectal cancer diagnosis within 5 years History of pelvic radiotherapy within 5 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Karanicolas, MD PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
North York General Hospital
City
North York
State/Province
Ontario
ZIP/Postal Code
M2K 1E1
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Perianal Abscess Recurrence and Fistula Formation: Antibiotics Following Incision and Drainage Trial

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