Vacuum therapy for treating perianal abscesses and fistulas
Semiflex Assisted Vacuum Therapy for Perianal Abscesses/Sinuses and Fistula: a Pilot Study
This study is testing a new vacuum therapy using a special catheter to see if it can help people with perianal abscesses and fistulas, especially those with Crohn's disease, heal better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06446635 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility and efficacy of a novel Semiflex Dome Catheter System for vacuum therapy in patients with perianal abscesses, sinuses, and fistulas, particularly those related to Crohn's disease. The study aims to provide a more effective treatment option by utilizing a catheter designed to conform to various fistula shapes and sizes. It is a prospective, multicenter feasibility study involving patients aged 18 to 80 years. The intervention involves the insertion of a tailored catheter to facilitate healing.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with perianal abscesses, sinuses, or (Crohn's) perianal fistulas.
Not a fit: Patients with more than two external perianal openings or rectovaginal fistulas may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing outcomes for patients suffering from perianal abscesses and fistulas.
How similar studies have performed: While vacuum therapy has been used in various wound healing contexts, this specific application for perianal conditions is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Perianal abscess/sinus or (Crohn's) perianal fistula * ≥ 18 years and \< 80 years * Written informed consent Exclusion criteria * Patients with more than 2 external perianal openings * Rectovaginal fistula * Life expectancy \< 2 years * Dementia or altered mental status that would prohibit the understanding and giving of informed consent
Where this trial is running
Amsterdam
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: AJM Pronk
- Email: a.pronk@amsterdamumc.nl
- Phone: +31642665328
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.