A Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant

Cohera Medical

Status: Terminated

Conditions: Colorectal and Ileorectal Anastomosis; Coloanal and Ileoanal Anastomosis; Colocolic and Ileocolic Anastomosis

Treatments: Device: Sylys® Surgical Sealant; Procedure: Stapled Anastomosis Colectomy Procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT02841891

PRO-106-0129

Details and patient eligibility

About

The Cohera Sylys® Surgical Sealant study is a prospective, randomized, controlled, multicenter clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) in patients undergoing a colectomy procedure with a stapled anastomosis.

Enrollment: 58 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be 22 years of age or older
• Be scheduled for a colectomy procedure with a stapled anastomosis
• At time of surgery, has a completed anastomosis that is able to be visualized and is accessible to allow for circumferential sealant application with minimal bowel manipulation (≥90%)
• Completed anastomosis must be at a location where a WCE can be performed to evaluate for a sub-clinical leak
• Agree to return for all follow-up evaluations and procedures specified in the protocol
• Understand and give informed consent

Exclusion criteria

• Albumin < 3 g/dL
• ASA score (American Society of Anesthesiologists) ≥ 4
• Neutropenia ≤ 800 cells/µl
• Pregnant at time of surgery
• Has AIDS (HIV positive not excluded)
• Has neutropenia (IBD and steroid use not excluded)
• Has a known blood clotting disorder requiring treatment
• Has any condition known to effect wound healing, such as collagen vascular disease
• Has known or suspected allergy or sensitivity to any test materials, reagents, or WCE contrast materials
• Has undergone chemotherapy within 4 weeks of the anastomosis procedure and/or radiation within 3 days of the anastomosis procedure
• Concurrently using fibrin sealants or other anastomosis care devices
• Emergency surgery for abdominal indications
• Has undergone a colectomy procedure in the previous two months
• Has an emergent infection related to a previous colectomy procedure
• Is scheduled to undergo a Hartmann's procedure
• Is scheduled to undergo trans-anal endoscopic microsurgery (TEM)
• Is scheduled to undergo procedure using omental wrapping
• Is participating in another medical device trial involving colectomy with anastomosis

First 20 subjects ONLY:

• Is diagnosed with high risk cancer as determined by preoperative clinical evidence or diagnostic imaging (if patient's cancer stage has been downstaged through treatment prior to baseline screening, subject is allowed to be included):

• Lymph Node Cancer Stage: N2
• Cancer Tumor Size: T4
• Circumferential resection margin: CRM+ (Positive)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Test

Experimental group

Description:

Test group will receive Sylys® Surgical Sealant as an adjunct to standard closure of stapled anastomosis in colectomy procedure.

Treatment:

Device: Sylys® Surgical Sealant

Control

Active Comparator group

Description:

Control group will receive standard of care closure of stapled anastomosis in colectomy procedure without Sylys® Surgical Sealant.

Treatment:

Procedure: Stapled Anastomosis Colectomy Procedure