Dermabond PRINEO for Total Shoulder Arthroplasty
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/8/2019 |
| Start Date: | March 20, 2019 |
| End Date: | March 20, 2020 |
| Contact: | Josef Eichinger, MD |
| Email: | eichinge@musc.edu |
| Phone: | 843-876-0111 |
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.
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 ispilateral 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.
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
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