Dermabond PRINEO for Total Shoulder Arthroplasty

Investigation of a New Skin Closure Device, Dermabond PRINEO, for Total Shoulder Arthroplasty: A Randomized, Controlled Trial

This is a research study to find out whether wound closure (the process of closing the surgical wound after the procedure is complete) with Dermabond PRINEO Skin Closure System (PRINEO) will be faster and improve wound healing compared to standard closing methods after total shoulder replacement. The PRINEO system involves using running stitches to close the wound, and then taping over the sutures with a sticky film that holds the wound closed.

Subjects will be included if:

• They are 18 years or older;
• They are undergoing primary total shoulder arthroplasty by the principal and co-investigator.
• They are willing and have the capacity to provide informed consent;
• They expect to continue their post-operative follow up care with their operating surgeons at Medical University of South Carolina (MUSC).

Subjects will be excluded if:

• They have a unique, identifying tattoo or skin marking within 2 inches of intended site of surgical incision
• They self-report a known hypersensitivity to cyanoacrylate, formaldehyde, benzalkonium chloride, or pressure sensitive adhesive;
• They self-report or have a documented prior ipsilateral shoulder arthroplasty or other open ipsilateral shoulder surgery utilizing the delto-pectoral approach;
• Their medical record shows that they are HIV positive or otherwise immunocompromised;
• Their medical record shows a skin abnormality or dermatological condition which affects skin healing;
• They report a personal or family history of significant keloid or significant hypertrophic scar formations, or other problems with wound healing.