Surgical management of perianal fistula using an ovine forestomach matrix implant

Abstract

Purpose Invasive surgical management of cryptoglandular perianal fistulas (PF) is challenging because of high recurrence rates and the potential for injury to the sphincter complex. In the present technical note, we introduce a minimally invasive treatment for PF using a perianal fistula implant (PAFI) comprising ovine forestomach matrix (OFM). Methods This retrospective observational case series highlights 14 patients who had undergone a PAFI procedure at a single center between 2020 and 2023. During the procedure, previously deployed setons were removed and tracts were de-epithelialized with curettage. OFM was rehydrated, rolled, passed through the debrided tract, and secured in place at both openings with absorbable suture. Primary outcome was fistula healing at 8 weeks, and secondary outcomes included recurrence or postoperative adverse events. Results Fourteen patients underwent PAFI using OFM with a mean follow-up period of 37.6 ± 20.1 weeks. In follow-up, 64% (n = 9/14) had complete healing at 8 weeks and all remained healed, except one at last follow-up visit. Two patients underwent a second PAFI procedure and were healed with no recurrence at the last follow-up visit. Of all patients that healed during the study period (n = 11), the median time to healing was 3.6 (IQR 2.9–6.0) weeks. No postprocedural infections nor adverse events were noted. Conclusions The minimally invasive OFM-based PAFI technique for PF treatment was demonstrated to be a safe and feasible option for patients with trans-sphincteric PF of cryptoglandular origin.

Ovine Forestomach Matrix Implant for Surgical Management in Perianal Fistulas: A Retrospective Case-Series

“…With no consensus on a standard surgical approach, traditional and biologic stula plugs, or implants, have been an increasingly common reported solution [9]. In this study, OFM was used as a PAFI due to its demonstrated ability to augment healthy soft tissue regeneration in chronic defects, its ease of use, low cost, and demonstrated previous e cacy as a PAFI [20]. In this retrospective case series of 25 patients, OFM was able to achieve healing and maintain closure in 76% (n = 19) of cases at 12-weeks with a median healing time of 4.5 weeks with a median single application (Table 4).…”

“…For this reason, biologic stula plugs have demonstrated success in limiting incontinence and surgical complications but exhibit varying degrees of clinical e cacy. More recently, a biologic implant derived from ovine forestomach matrix (OFM) has been studied as a novel alternative to the traditional plugs with promising early success [20]. OFM is a decellularized extracellular matrix (dECM) that preserves inherent tissue architecture and retains biomolecules crucial to the tissue regeneration process [21].…”

“…Additionally, OFM has demonstrated the ability to recruit mesenchymal stromal cells [24], stimulate cell proliferation and angiogenesis [25], all of which are key components of tissue regeneration. OFM has been further employed in the regeneration of multiple types of contaminated soft tissue defects, in addition to the recent use as a PAFI [20,[26][27][28][29]. The combination of initial clinical e cacy in PFs and in other contaminated, in ammatory tissues has led the authors to perform a larger single-center, retrospective case series to validate the previously published PAFI pilot study in a new, larger patient population.…”