N/A
Completed N=89
Dermabond PRINEO for Total Shoulder Arthroplasty
Surgical Wound · Shoulder Arthritis · Surgical Incision
Source: ClinicalTrials.gov NCT03860181 ↗
Enrolled (actual)
89
Serious AEs
2.3%
Results posted
Aug 2021
Primary outcomePrimary: Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control. — 627.83; 304.75; 568.53; 420.77 Dollars
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control. |
627.83; 304.75; 568.53; 420.77 | — |
| PRIMARY Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls |
10; 10; 10; 10 | — |
| PRIMARY Mean Closure Time Per Centimeter of Incision |
1.3; 0.65; 1.1; 0.72 | — |
| SECONDARY Median Overall Opinion Score Reported by Operating Surgeon |
2; 1; 2; 1 | — |
| SECONDARY Median Wound Inflammation Score (AIRE) Reported by Operating Physician |
0; 0; 0.5; 0 | — |
| SECONDARY Median Scar Assessment (POSAS) by Operating Surgeon |
9; 6; 10; 6 | — |
| SECONDARY Wound Cosmesis (MHCS) Score by Operating Physician |
2; 1; 3; 1 | — |
| SECONDARY Differences Between Patient and Surgeon Total POSAS Scores |
11.5; 9; 7; 6; 13; 10 | 0.896 |
| SECONDARY Median Overall Opinion Score Reported by Plastic Surgeons |
5; 3; 5; 4 | — |
| SECONDARY Median Scar Assessment (POSAS) by Plastic Surgeon |
25; 18; 25; 20.5 | — |
| SECONDARY Wound Cosmesis (MHCS) Score by Plastic Surgeon |
2; 1; 3; 1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03860181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.