At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Undergoing primary total shoulder arthroplasty performed by the principal or co-investigator
- ✓Willing and able to provide informed consent
- ✓Able to continue post-operative follow-up care at MUSC with operating surgeons
- ✕Tattoo or skin marking within 2 inches of intended surgical incision site
- ✕Known hypersensitivity to cyanoacrylate, formaldehyde, benzalkonium chloride, or pressure sensitive adhesive
- ✕Prior ipsilateral shoulder arthroplasty or other open ipsilateral shoulder surgery via deltopectoral approach
- ✕HIV-positive or otherwise immunocompromised status
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Investigation of a New Skin Closure Device, Dermabond PRINEO, for Total Shoulder Arthroplasty: A Randomized, Controlled Trial
In Brief
A clinical study evaluating Subcuticular Sutures - Surgeon 1, Metal Staples - Surgeon 2, and 2 other interventions for Surgical Wound and 2 related conditions. Completed, enrolled 89 participants across 1 site.
Detailed 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 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.
Study Details
Timeline
Interventions
This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.