40
Participants
Start Date
April 14, 2023
Primary Completion Date
May 1, 2025
Study Completion Date
August 1, 2025
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."
RECRUITING
Amsterdam UMC, Amsterdam
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER