EUCTR2019-001002-18-ES
Active, Not Recruiting
Phase 1
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.
Hospital Universitari Germans Trias i Pujol0 sites210 target enrollmentFebruary 1, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Abscess and anal fistulas
- Sponsor
- Hospital Universitari Germans Trias i Pujol
- Enrollment
- 210
- Status
- Active, Not Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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)
Outcomes
Primary Outcomes
Not specified
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