Status:
COMPLETED
Dermabond PRINEO for Total Shoulder Arthroplasty
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Surgical Wound
Shoulder Arthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2020
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT03860181
Start Date
March 25 2019
End Date
June 23 2020
Last Update
October 1 2021
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425