Antibiotics after drainage of perianal abscess to avoid fistula formation

Pathophysiological mechanisms in the development of anal fistula. Oral antibiotics after anal abscess drainage to diminish perianal Fistula Formation: a multicenter, randomized, observer-blind, placebo-controlled clinical trial. - O.F.F.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001002-18-ES

Enrollment

210

Registered

2021-02-01

Start date

2021-05-04

Completion date

Unknown

Last updated

2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abscess and anal fistulas

Interventions

Trade Name: Ciprofloxacin Product Name: Ciprofloxacin Pharmaceutical Form: Tablet INN or Proposed INN: ciprofloxacin CAS Number: 85721-33-1 Other descriptive name: CIPROFLOXACIN Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 18 years or more Both genders Clinical diagnosis of anal abscess (acute inflammatory signs and presence of a purulent collection in the perianal area) seen or confirmed through punction aspiration of purulent material with needle. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: Inflammatory bowel disease Anal surgical history Anal fistula alredy konwn Anal carcinoma and/or pelvic radiotherapy Anal trauma history "horse shoe" abscess Inmunodeficiency, diabetes, pregnancy or lactation, heart valve disease or prosthetic valve carriers Spontaneous drainage of abscess Antibiotics use Contraindications of ciprofloxacin according to SPC (hypersensitivity to the active principle, or to other quinolones or to any of the excipients; concomitant administration of ciprofloxacin and tizanidine) - Contraindications of metronidazole according to SPC (hypersensitivity to imidazoles or to any of the excipients) -Pregnancy and lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: Demonstrate that oral antibiotic after perianal abscess debridement decreases the anal fistula incidence;Secondary Objective: Show the clinical benefit (quality of life included) of oral antibiotic after perianal abscess debridement in development of anal fistula Describe the pacients under risk of anal fistulas aparition after anal abscess episode.;Primary end point(s): Fistula anal presence (Parks classification);Timepoint(s) of evaluation of this end point: 1st month 3rd month 6th month 9th month	—

Measure

Time frame

Main Objective: Demonstrate that oral antibiotic after perianal abscess debridement decreases the anal fistula incidence;Secondary Objective: Show the clinical benefit (quality of life included) of oral antibiotic after perianal abscess debridement in development of anal fistula Describe the pacients under risk of anal fistulas aparition after anal abscess episode.;Primary end point(s): Fistula anal presence (Parks classification);Timepoint(s) of evaluation of this end point: 1st month 3rd month 6th month 9th month

—

Secondary

Measure	Time frame
Secondary end point(s): Ultrasonography to fistula examination;Timepoint(s) of evaluation of this end point: 6th months	—

Countries

Spain

Contacts

Public ContactServei de Cirurgia

Hospital Universitari Germans Trias i Pujol

davidpares.germanstrias@gencat.cat+34934978655

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026