Clinical Evaluation of Cohera Sylys Surgical Sealant as an Adjunct to Standard Bowel Anastomosis Closure

Inclusion criteria

• Be at least 18 years of age
• Be in good general health in the opinion of the investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications
• Be scheduled for an ileostomy reversal procedure
• Be willing to follow instructions for incision care
• Agree to return for all follow-up evaluations specified in this protocol
• Sign informed consent

Exclusion criteria

• Anesthesia risk judged to be higher than ASA2
• Have severe co-morbid conditions that pose a high risk for surgery and adequate recovery (e.g., heart disease)
• Any condition involving compromised immune system
• Any condition known to effect wound healing, such as collagen vascular disease
• Known blood clotting disorder
• Be receiving antibiotic therapy for pre-existing condition or infection
• Concurrent use of fibrin sealants or other anastomosis care devices
• Be currently taking systemic steroids or immunosuppressive agents
• Have known or suspected allergy or sensitivity to any test materials or reagents
• Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study