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

AimPermacol 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. MethodPatients (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 12months post-treatment, with the primary end-point being healing at 6months. Faecal continence and patient satisfaction were surveyed at each follow-up; adverse events (AEs) were monitored throughout the follow-up. ResultsAt 6months postsurgery, 56.7% of patients were healed and the percentage healed was largely maintained, with 53.5% healed at 12months. 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. ConclusionPermacol paste is a promising sphincter-preserving treatment for anal fistulae and has minimal adverse side-effects.