Semiflex Assisted Vacuum Therapy for Perianal Abscesses/Sinuses and Fistula: a Pilot Study

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Jun 1, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients suffering from perianal abscesses, sinuses, or fistulas, which are common and often painful conditions that can significantly impact quality of life. The researchers are testing a special vacuum therapy system called the Semiflex Dome System. This system uses a tailored catheter to help drain and heal these conditions more effectively and comfortably than traditional methods.

To participate in this study, you must be at least 18 years old and have either a perianal abscess or a perianal fistula, especially if it's related to Crohn's disease. Participants will have the Semiflex catheter placed under general anesthesia, and the treatment will last from two to four weeks, depending on your specific condition. Throughout the trial, the medical team will monitor how well the catheter works, how comfortable you feel with it, and whether it helps your condition improve. It's important to note that the materials used are certified for safety, and there are no known additional risks from this new therapy.

Gender

ALL

Eligibility 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