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

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

April 14, 2023

Primary Completion Date

May 1, 2025

Study Completion Date

August 1, 2025

Conditions
Perianal FistulaPerianal Fistula Due to Crohn's DiseasePerianal Abscess
Interventions
DEVICE

Semiflex Dome Catheter System

"Abces: In patients that present with a perianal abscess/sinus the semiflex dome catheter is inserted under general anesthesia. A small cut is made to drain and irrigate the septic sinus.~Fistula: Under general anesthesia the seton is removed, the internal opening is excised and the internal opening is closed with a 2-0 Vicryl cross stitch.~Both: Before surgery, the length of the tract is measured on MRI or CT. A Semiflex Catheter with the appropriate length and a diameter is selected. If during surgery appears that this is not the appropriate size, a different size catheter can be used. The catheter is fixed on a Renasys Adhesive gel patch (Smith and Nephew). The catheter is connected with a tubing system to a vacuum pomp with an average vacuum pressure of 80 cm H2O. The tube will be taped on the patient. After every 2-3 days the catheter will be exchanged by a 3-6 mm shorter catheter."

Trial Locations (1)

Unknown

RECRUITING

Amsterdam UMC, Amsterdam

All Listed Sponsors
lead

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER