Dermabond PRINEO for Total Shoulder Arthroplasty
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|ClinicalTrials.gov Identifier: NCT03860181|
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : April 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Surgical Wound Shoulder Arthritis Surgical Incision||Procedure: Subcuticular Sutures Procedure: Metal Staples Device: PRINEO||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Investigation of a New Skin Closure Device, Dermabond PRINEO, for Total Shoulder Arthroplasty: A Randomized, Controlled Trial|
|Actual Study Start Date :||March 25, 2019|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||August 31, 2020|
Active Comparator: Traditional Dermabond + subcuticular sutures
Subcuticular sutures with traditional Dermabond applied to incision.
Procedure: Subcuticular Sutures
This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
Active Comparator: Metal staples
Procedure: Metal Staples
This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
Experimental: Dermabond PRINEO
Dermabond PRINEO System
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.
- Mean Time required for wound closure [ Time Frame: Up to 20 minutes during surgery for each patient. ]Manually recording time to wound closure during the operation using a stop watch
- Wound Cosmesis [ Time Frame: Up to 3 months post surgery ]Images of the healing wound after surgery will be assessed according to the Modified Hollander Cosmesis Scale (0 to 6, with 6 being ideal), and the
- Scar assessment [ Time Frame: Up to 3 months post surgery ]Images of the healing wound will be assessed according to the Patient and Observer Scar Assessment Scale (0 to 10, 10 being ideal)
- Wound inflammation [ Time Frame: Up to 3 months post surgery ]Images of the healing wound will be assessed according to the Acute Inflammatory Response Evaluation score (0 to 3, 0 being ideal).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860181
|Contact: Josef Eichinger, MDemail@example.com|
|Contact: Zora Mayofirstname.lastname@example.org|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Josef K Eichinger, MD|
|Principal Investigator:||Josef Eichinger, MD||Medical University of South Carolina|