Trial Outcomes & Findings for Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft (NCT NCT00610207)
NCT ID: NCT00610207
Last Updated: 2016-02-02
Results Overview
Fistula closure is defined as absence of drainage at the external fistula opening.
TERMINATED
NA
21 participants
12 months
2016-02-02
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft
Baseline characteristics by cohort
| Measure |
Biodesign® Anal Fistula Plug
n=18 Participants
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.
|
|---|---|
|
Age, Continuous
|
40.2 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
|
Height
|
66 inches
n=39 Participants
|
|
Weight
|
148 pounds
n=39 Participants
|
|
Body Mass Index
|
24 kg/m^2
n=39 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Three single tract fistula patients were lost to follow-up and were excluded from the analysis.
Fistula closure is defined as absence of drainage at the external fistula opening.
Outcome measures
| Measure |
Biodesign® Anal Fistula Plug
n=18 Participants
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.
|
|---|---|
|
Fistula Closure (Patient Based)
|
10 participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Three single tract fistula patients were lost to follow-up and were excluded from the analysis.
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.
Outcome measures
| Measure |
Biodesign® Anal Fistula Plug
n=25 tracts
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.
|
|---|---|
|
Fistula Closure (Tract Based)
|
17 tracts
|
Adverse Events
Biodesign® Anal Fistula Plug
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jason Hodde, Clinical Affairs Manager
Cook Biotech, Incorporated
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60