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

Cohera Medical

Status

Completed

Conditions

Stoma Reversal Procedure

Treatments

Device: Sylys Surgical Sealant

Study type

Interventional

Funder types

Industry

Identifiers

NCT02196519

PRO-106-0028

Details and patient eligibility

About

A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the anastomotic junction created during a stoma reversal procedure.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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