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

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 10 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 end-point 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 postsurgery, 56.7% of patients were healed and the percentage healed was largely maintained, with 53.5% healed at 12 months. Regarding AEs, 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 is a promising sphincter-preserving treatment for anal fistulae and has minimal adverse side-effects.

Keywords: Anal fistula; Permacol™ collagen paste; faecal continence; sphincter-preserving technique.