Anal Fistula, Crohn's Disease
Conditions
Keywords
Anal fistula, fistula in ano, anorectal fistula, Crohn's Disease
Brief summary
Healing anal fistulas in Crohn's patients with an anal fistula plug.
Detailed description
The purpose of this study is to determine whether the Surgisis anal fistula plug is effective in healing anal fistulas in patients diagnosed with Crohn's Disease.
Interventions
DEVICESurgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)
Surgical placement of the Surgisis AFP is performed under general anesthesia
Sponsors
Cook Biotech Incorporated
Cook Group Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is diagnosed with Crohn's Disease * Patient has a chronically draining anal fistula of Crohn's origin * Patient is 18 years old or older * Patient has signed an informed consent
Exclusion criteria
* Patient is pregnant or lactating * Patient has peri-anal drainage with originates from outside the anorectal tract
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fistula Closure (Patient Based) | 12 months | Fistula closure is defined as absence of drainage at the external fistula opening. |
| Fistula Closure (Tract Based) | 12 months | Fistula closure is defined as absence of drainage at the external fistula opening. An anorectal fistula is an inflammatory tract or connection between the epithelialized surface of the anal canal and most frequently, the perianal skin or perineum. It is possible to have multiple fistula tracts present on a patient. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Biodesign® Anal Fistula Plug Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.
Three single tract fistula patients were lost to follow-up and were excluded from the analysis. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Biodesign® Anal Fistula Plug |
|---|---|
| Age, Continuous | 40.2 years |
| Body Mass Index | 24 kg/m^2 |
| Height | 66 inches |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 9 Participants |
| Weight | 148 pounds |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Fistula Closure (Patient Based)
Fistula closure is defined as absence of drainage at the external fistula opening.
Time frame: 12 months
Population: Three single tract fistula patients were lost to follow-up and were excluded from the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Biodesign® Anal Fistula Plug | Fistula Closure (Patient Based) | 10 participants |
Primary
Fistula Closure (Tract Based)
Fistula closure is defined as absence of drainage at the external fistula opening. An anorectal fistula is an inflammatory tract or connection between the epithelialized surface of the anal canal and most frequently, the perianal skin or perineum. It is possible to have multiple fistula tracts present on a patient.
Time frame: 12 months
Population: Three single tract fistula patients were lost to follow-up and were excluded from the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Biodesign® Anal Fistula Plug | Fistula Closure (Tract Based) | 17 tracts |