Final results of a European, multicentre, prospective, observational study of Permacol (TM) collagen paste injection for the treatment of anal fistula

Pasquale Giordano (Lead / Corresponding author), Pierpaolo Sileri, Steen Buntzen, Angelo Stuto, Joseph Nunoo-Mensah, Leonardo Lenisa, Baljit Singh, Ole Thorlacius-Ussing, Ben Griffiths, Dorin Ziyaie

Research output: Contribution to journalArticle

7 Citations (Scopus)
137 Downloads (Pure)

Abstract

Aim: Permacol(™) collagen paste (Permacol(™) paste) is an acellular cross-linked porcine dermal collagen matrix suspension for use in soft tissue repair. The use of Permacol(™) paste in the filling of anorectal fistula tract is a new sphincter-preserving method for fistula repair. The MASERATI100 study was a prospective, observational clinical study with the objective to assess the efficacy of Permacol(™) collagen paste for anal fistula repair in 100 patients.

Method: Patients (N=100) with anal fistula were treated at ten European surgical sites with a sphincter-preserving technique using Permacol(™) paste. Fistula healing was assessed at 1, 3, 6, and 12 months post-treatment, with the primary endpoint being healing at 6 months. Faecal continence and patient satisfaction were surveyed at each follow-up; adverse events (AEs) were monitored throughout the follow-up.

Results: At 6 months post-surgery, 56.7% of patients were healed, and the percentage healed was largely maintained, with 53.5% healed at 12 months. 29.0% of patients had at least one AE, and 16.0% of patients had one or more procedure-related AE. Most AEs reported were minor and similar to those commonly observed after fistula treatment, and the incidence of serious adverse events was low (4.0% of patients). Regardless of treatment outcome, 73.0% of patients were satisfied or very satisfied with the procedure.

Conclusion: Permacol(™) paste provides a promising sphincter-preserving treatment for anal fistulas with minimal adverse side-effects.

Original languageEnglish
Pages (from-to)243-251
Number of pages9
JournalColorectal Disease
Volume20
Issue number3
Early online date11 May 2017
DOIs
Publication statusPublished - Mar 2018

    Fingerprint

Keywords

  • Anal fistula
  • Permacol™ collagen paste
  • faecal continence
  • sphincter-preserving technique

Cite this

Giordano, P., Sileri, P., Buntzen, S., Stuto, A., Nunoo-Mensah, J., Lenisa, L., Singh, B., Thorlacius-Ussing, O., Griffiths, B., & Ziyaie, D. (2018). Final results of a European, multicentre, prospective, observational study of Permacol (TM) collagen paste injection for the treatment of anal fistula. Colorectal Disease, 20(3), 243-251. https://doi.org/10.1111/codi.13715