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

BackgroundReducing 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.MethodsThis 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.ResultsSixteen 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.ConclusionsIn 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.