Investigation of a New Skin Closure Device, Dermabond PRINEO, for Total Shoulder Arthroplasty: A Randomized, Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls
Overview
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 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls
Time Frame: 3 months post-operatively
Patient satisfaction ratings were on a scale from 0-10, where 0 = very dissatisfied and 10 = very satisfied.
Mean Closure Time Per Centimeter of Incision
Time Frame: Immediate/at time of surgery
This closure time was measured from the first stitch for closure to the application of the wound dressing. The incision length was measured immediately after closure.
Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control.
Time Frame: 3 months post-operative
Closure cost was calculated by evaluating the cost of wound closure products ($) per patient, plus the cost of the operating room ($) per minute, multiplied by the closure time (minutes) per centimeter of incision length, then multiplied by the average incision length (cm) per patient.
Secondary Outcomes
- Median Scar Assessment (POSAS) by Plastic Surgeon(Up to 3 months post surgery)
- Median Overall Opinion Score Reported by Operating Surgeon(Up to 3 months)
- Median Overall Opinion Score Reported by Plastic Surgeons(Up to 3 months)
- Wound Cosmesis (MHCS) Score by Plastic Surgeon(Up to 3 months post surgery)
- Median Wound Inflammation Score (AIRE) Reported by Operating Physician(Up to 3 months post surgery)
- Median Scar Assessment (POSAS) by Operating Surgeon(Up to 3 months post surgery)
- Wound Cosmesis (MHCS) Score by Operating Physician(Up to 3 months post surgery)
- Differences Between Patient and Surgeon Total POSAS Scores(3 months post-operatively)
Investigators
Josef Eichinger
Professor
Medical University of South Carolina