Clinical Evaluation of the Cohera Sylys* Surgical Sealant as an adjunct to standard bowel anastomosis closure - PRO-106-0028

Cohera Medical0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•* 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 the informed consent.

•* 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

发起方

Cohera Medical