CTRI/2017/06/008795
Completed
未知
A Feasibility Study to Evaluate the Safety and Effectiveness ofMAR-CUTIS®, Topical Skin Adhesive, in Holding Closed Easily ApproximatedSkin Edges of Wounds from Surgical Incisions
Medical Adhesive Revolution GmbH0 sites10 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Patients undergoing a planned elective CABG procedure (likely to have incision for saphenous vein harvesting) and have easily approximated skin edges of wounds from incisions.
- Sponsor
- Medical Adhesive Revolution GmbH
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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,
Outcomes
Primary Outcomes
Not specified
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