An interventional study of Semiflex Dome Catheter System in Perianal Fistula, Perianal Fistula Due to Crohn's Disease and Perianal Abscess, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-06.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment
Rationale: Perianal fistulas are a common, invalidating problem for which a more effective and widely applicable treatment is necessary. Vacuum therapy has become one of the main pillars for management of a wide variety of (chronic) wound healing problems. A novel catheter set was developed for vacuum therapy of perianal abscesses/sinuses and fistulas: The Semiflex Dome System. This system will allow for a better and faster treatment and it will offer conformability with various fistula shapes and sizes.
Objective: With this pilot study, the investigators aim to test our novel catheter set for vacuum therapy of perianal abscesses/sinuses and fistulas for feasibility and efficacy.
Study design: The design of this prospective, multicentre study is a feasibility study.
Study population: Patients (≥ 18 years) with (Crohn's) perianal fistulas and patients with perianal abscesses/sinuses are eligible.
Intervention: A tailored (length and diameter) Semiflex dome catheter is inserted under general anaesthesia, after 6 weeks of seton drainage in patients with a perianal fistula and right away in patients with a perianal abscess/sinus. The catheter is fixed on a Renasys Adhesive gel patch (Smith and Nephew) and is connected with a tubing system to a vacuum pomp with an average vacuum pressure of 80 cm H2O. After two - three days the catheter will be exchanged by a shorter catheter in the outpatient setting. The therapy is continued for a maximum of four weeks in patients with a perianal abscess/sinus and two weeks in patients with perianal fistulas.
Main study parameters/endpoints: The primary objective of the study is the feasibility of the methodology with respect to smoothness of insertion and changing the semiflex catheters, capability of proper fixation of the catheter and maintaining vacuum for more than 48 hours, and compliance to the therapy in terms of pain and discomfort. Secondary objectives are efficacy of drainage of the perianal abscess/sinus, efficacy of curing the perianal abscess/sinus in terms of complete collapse of the sinus and disappearance of induration, efficacy of management of perianal fistula in terms of clinical and radiological healing, and safety in terms of complications.
Nature and extent of the burden and risks associated with participation: The Semiflex Dome Catheter System will be placed in patients with perianal fistulas and perianal abscess/sinus who would otherwise be treated using prior-art passive drainage catheters or repurposed vacuum-assisted closure therapy sponges. There are no known additional risks stemming from the proposed therapy. The Semiflex Dome Catheter System is made entirely of medical-grade silicone certified with ISO 10993- 05 and ISO 10993-10. The catheters will be connected with a tube configured to be connected to a CE certified vacuum generating system.
Sample size: Since this is a pilot study no sample size is required. The pilot study will consist of 2 parts. In the first part, 10 patients in each study group will be included and it will be assessed per study group if the catheter meets the proof of principle. After a positive result in one or both study groups, the second part of the study will start. 10 patients in each study group will be included. The proposed treatment protocol is considered feasible if at least 70% of the Semiflex dome catheter treatment per study group meets the four primary objectives.
152 studies on the registry are indexed under Abscess; 22 are open to participants now.
This study's planned enrollment of 40 is below the median of 110 across 120 interventional studies indexed under Abscess.
Browse Abscess studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 183 are open to participants now.
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Exclusion criteria
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The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Semiflex Dome Catheter System
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.
Smoothness of insertion and exchanging of the Semiflex catheter
The doctor will determine how easy the catheter is to insert on a scale of 0-10, with 0 being very difficult and 10 being very easy. A score \<5 is considered as not smooth. This will be scored individually and if all primary outcome measures are met, the treatment is considered successful in this participant.
Time frame: 3 months
Proper fixation of the Semiflex catheter
The system is properly fixed if it has been in place for \>48 hours. If the system becomes loose before 48 hours, it is considered as not properly fixed. This will be scored individually and if all primary outcome measures are met, the treatment is considered successful in this participant.
Time frame: 48 hours
Maintaining vacuum for more than 48 hours
The system is properly vaccuum if it has been vacuum for \>48 hours. If the system looses vaccuum before 48 hours, it is considered as not properly vaccuum. This will be scored individually and if all primary outcome measures are met, the treatment is considered successful in this participant.
Time frame: 48 hours
Compliance to the therapy in terms of pain and discomfort
The patient gives a painscore after the Semiflex exchange on a scale of 0-10, with 0 being not painfull and 10 being very painfull. A score \>5 is considered as too painfull. This will be scored individually and if all primary outcome measures are met, the treatment is considered successful in this participant.
Time frame: 3 months
Efficacy of drainage of the perianal abscess/sinus
Is the Semiflex capable of draining the perianal abcess/sinus. 1 month after therapy a clinical evaluation will be done to see if the perianal abscess/ sinus is healed. Clinical closure is defined as closure of the external opening without discharge of pus on palpation. After three months a MRI is made to see if the perianal abscess/sinus is radiological healed. Radiological healing defined as complete fibrosis of the abscess/sinus on MRI.
Time frame: 3 months
Efficacy of management of perianal fistula in terms of clinical and radiological healing
Is the Semiflex capable of draining the perianal fistula. 1 month after therapy a clinical evaluation will be done to see if the perianal fistula is healed. Clinical closure is defined as closure of the external opening without discharge of pus or feaces on palpation. After three months a MRI is made to see if the perianal fistula is radiological healed. Radiological healing defined as complete fibrosis of the perianal fistual.
Time frame: 3 months
Safety in terms of complications
All complications related to the Semiflex treatment will be recorded during the follow-up of three months.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for May 2025, 24 months after the start.
Of 21 interventional studies with no phase under Abscess, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 56. This study's planned 24 months is below that.
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