Final results of a European, multi-centre, prospective, observational Study of Permacolâ„¢ collagen paste injection for the treatment of anal fistula.

Giordano, Pasquale; Sileri, Pierpaolo; Buntzen, Steen; Stuto, Angelo; Nunoo-Mensah, Joseph; Lenisa, Leonardo; Singh, Baljit; Thorlacius-Ussing, Ole; Griffiths, Ben; Ziyaie, Dorin

AIM Permacolâ„¢ collagen paste (Permacolâ„¢ paste) is an acellular cross-linked porcine dermal collagen matrix suspension for use in soft tissue repair. The use of Permacolâ„¢ 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 Permacolâ„¢ 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 Permacolâ„¢ 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 Permacolâ„¢ paste provides a promising sphincter-preserving treatment for anal fistulas with minimal adverse side-effects. This article is protected by copyright. All rights reserved.