A Feasibility Study to Evaluate the Safety and Effectiveness ofMAR-CUTISÂ®, Topical Skin Adhesive, in Holding Closed Easily ApproximatedSkin Edges of Wounds from Surgical Incisions

Medical Adhesive Revolution GmbH0 个研究点目标入组 10 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Subject age of > 18 years and Male only
•2. Subject undergoing a planned elective Coronary artery bypass grafting (CABG) surgical procedure and likely to have an incision for saphenous vein harvesting.
•3. Subject with not more than two co-morbidities and in relatively 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.
•4. Be willing to follow instructions for incision care as instructed by the investigator, and refrain from swimming or soaking in a tub during the first 10 days of the study.
•5. Subject or their legal representative is willing and able to sign an Ethics Committee approved informed consent form and agrees to comply with study requirements.

•1. Have peripheral vascular disease;
•2. Have insulin dependent diabetes mellitus;
•3. Be known to have a blood clotting disorder;
•4. Be receiving antibiotic therapy for pre-existing condition or infection;
•5. Be known to be HbsAg positive, HIV positive, HCV positive or otherwise immunocompromised;
•6. Have known personal or family history of keloid formation or hypertrophy;
•7. Be currently taking systemic steroids;
•8. Have known or suspected allergy or sensitivity to urethane, cyanoacrylate, formaldehyde, tapes or adhesives;
•9. Have incision type or location known to have an incidence of cyanosis or other healing abnormalities;
•10. Have burst or stellate lacerations due to crush or hard blow,
•11. Have animal or human bites
•12. Have decubitus ulcer.
•13. Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrolment in this study;
•14. Lab values showing inflammation parameters above normal (e.g. Luc > 20,000)

发起方

Medical Adhesive Revolution GmbH