Sylys® surgical sealant: a safe adjunct to standard bowel anastomosis closure

Abstract

Background: Reducing the incidence of anastomotic leakages would benefit both patients and health care in general. Attempts to solve this problem have been disappointing thus far. Sylys® Surgical Sealant was developed as an extraluminal adjunct to standard closure techniques for bowel anastomosis procedures. We describe the results of a first-in-man study in which Sylys® Surgical Sealant is used. The aim of this study was to evaluate the safety of Sylys® Surgical Sealant in stoma reversal procedures. Methods: This prospective, multicenter, non-randomized, first-in-man industry initiated study was performed in two independent hospitals in the Netherlands. The study population consisted of adults who were scheduled for an open ileostomy reversal procedure. Exclusion critera were: patients with severe co-morbidities, patients receiving antibiotics, immunosuppressive agents or steroids for pre-existing conditions. Follow up was conducted during 3 months after surgery at the outpatient clinic. Results: Sixteen patients were eligible for inclusion. Twenty adverse events were recorded in 12 of the 16 treated patients (75%). None of these events were considered to be related to Sylys® Surgical Sealant. No clinical signs of anastomotic leakage were reported. Conclusions: In conclusion, this first-in-man application of Sylys® Surgical Sealant as an adjunct to standard bowel anastomosis closure techniques did not show any adverse effects in relation to the sealant in 16 patients.

Polymeric Tissue Adhesives

“…Acrylate/methacrylate polymerization (UV), 48,94,112,[128][129][130][132][133][134]185 o-nitrobenzene−amine (UV), 133,165,196 Acrylate/methacrylate polymerization (Visible light) 126,135,197 Self-curing Cyanoacrylates, 198 Polyurethane-based adhesive 199,200 Patch preforming Polyacrylic acid and NHS ester, 35,113,201,202 Polydopamine−polyacrylamide, 152 Polyacrylamide with adenine−thymine, 179 PEG−catechol based copolymer with hydrophobic motifs, 181,182 Oxidized alginate−catechol−polyacrylamide, 131 Alginate−Hyaluronic acid−dopamine 150…”

“…Another urethane-based adhesive, Sylys, based on triethoxysilane chemistry in combination with the same urethane chemistry as TissuGlu, 200 was recently developed. This product is intended to be used as an extraluminal adjunct to standard closure techniques for bowel anastomosis procedures.…”

An Off-the-Shelf Bioadhesive Patch for Sutureless Repair of Gastrointestinal Defects

“…Hence, various treatment strategies have been explored with the aim of improving mechanical sealing of GI defects through tissue adhesive sealants and/or structural reinforcement. For tissue adhesives and sealants, both biologic (e.g., fibrin, gelatin) and synthetic (e.g., PEG, polyurethane, cyanoacrylate) ones have been developed and investigated for repair of GI defects in academic and commercial settings (27)(28)(29). However, existing tissue adhesives and sealants are fraught with several limitations including mechanical mismatch with GI tissues (e.g., cyanoacrylate), rapid degradation (e.g., fibrin, gelatin), and/or weak sealing strength (11,(29)(30)(31)(32).…”

The use of mesenchymal stem cells in animal models for gastrointestinal anastomotic leak: A systematic review

“…[49] Technological attempts to reduce the incidence of AL have failed to establish efficacy when translated to clinical practice despite some succeeding in vivo. Interventions include devices to improve anastomosis formation through stapling and anastomotic line compression [50], anastomotic buttressing [51], intraluminal stents [52] gels [53], surgical sealants/adhesives [54,55], fibrin glue [56,57] and assessment of anastomotic blood supply [58]. Unfortunately, none of these technological advances has made an impact on the incidence of AL.…”

“…All those that disclosed detailed methods of the anastomo- Do the study animal models comply with ARRIVE guidelines? [18] Median ARRIVE guideline compliance across all 12 studies was 56% (IQR [45][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62]. Colorectal anastomosis studies had a greater compliance of 61% (IQR 61-63) compared to noncolorectal studies with 45% (IQR 42-47) (Table 7).…”