N/A
N=100
A Prospective, Multi-center, Observational Study of the Use of Permacol™ Collagen Paste to Treat Anorectal Fistulas
Anorectal Fistulas
Bottom Line
View on ClinicalTrials.gov: NCT01624350 ↗Enrolled (actual)
100
Serious AEs
6.0%
Results posted
Nov 2016
Primary outcome: Primary: Fistula Healing in Patients at 6 Months Following Surgery — 56.7; 43.3 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Permacol collagen paste (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fistula Healing in Patients at 6 Months Following Surgery |
56.7; 43.3 | — |
| SECONDARY Fistula Healing in Patients at 3 and 12 Months Following Surgery |
53.2; 53.5; 46.8; 46.5 | — |
| SECONDARY Participant Response to Quality of Life EQ-5D Questionnaire |
74; 77; 76; 72; 13; 7 | — |
| SECONDARY Fecal Incontinence |
-1.0; -1.1; -0.9 | — |
| SECONDARY Patient Satisfaction Between the First and Last Post-operative Visit |
37; 44; 39; 18; 8; 18 | — |
| SECONDARY Pain |
29; 45; 47; 47; 53; 44 | — |
Summary
This will be a prospective, multi-center, post-market, single arm observational study to collect clinical outcome data on the use of Permacol™ Collagen Paste in the treatment of anorectal fistulas.
The subjects will have baseline and day of surgery visits performed, and then subjects will return to the investigator for evaluation of defect and safety related morbidities at follow up visits scheduled at 1 month, 3 months, 6 months and 12 months post-surgery.
Eligibility Criteria
Key Inclusion Criteria
- Male or female subjects age 18 or older
- Subjects diagnosed with a solitary tract anorectal fistula of cryptoglandular origin
Key Exclusion Criteria
- History or suspicion of Inflammatory Bowel Disease (i.e.Crohn's Disease, Ulcerative Colitis)
- Subjects with secondary tracts, horseshoe fistulas, ano/recto-vaginal fistulas, or rectourethral fistulas
- Indication of an actively infected fistula/abscess (acute sepsis)
Data sourced from ClinicalTrials.gov (NCT01624350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.