Stoma Reversal Procedure
Conditions
Brief summary
A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the anastomotic junction created during a stoma reversal procedure.
Interventions
DEVICESylys Surgical Sealant
Sponsors
Cohera Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Adverse Events | 30 days |
Outcome results
None listed