Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446635
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-06
Brief Title:
Semiflex Assisted Vacuum Therapy for Perianal AbscessesSinuses and Fistula a Pilot Study
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Semiflex Assisted Vacuum Therapy for Perianal AbscessesSinuses and Fistula a Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Semiflex Pilot
Brief Summary:
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 abscessessinuses 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 abscessessinuses 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 Crohns perianal fistulas and patients with perianal abscessessinuses 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 abscesssinus 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 abscesssinus and two weeks in patients with perianal fistulas
Main study parametersendpoints 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 abscesssinus efficacy of curing the perianal abscesssinus 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 abscesssinus 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
Objective With this pilot study the investigators aim to test our novel catheter set for vacuum therapy of perianal abscessessinuses 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 Crohns perianal fistulas and patients with perianal abscessessinuses 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 abscesssinus 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 abscesssinus and two weeks in patients with perianal fistulas
Main study parametersendpoints 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 abscesssinus efficacy of curing the perianal abscesssinus 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 abscesssinus 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None