Clinical trial NCT03860181: Dermabond PRINEO for Total Shoulder Arthroplasty
Official title: Investigation of a New Skin Closure Device, Dermabond PRINEO, for Total Shoulder Arthroplasty: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound
Shoulder Arthritis
Surgical Incision
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2019-03-01
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control.
timeFrame: 3 months post-operative
measure: Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls
timeFrame: 3 months post-operatively
measure: Mean Closure Time Per Centimeter of Incision
timeFrame: Immediate/at time of surgery
Secondary outcomes:
measure: Median Overall Opinion Score Reported by Operating Surgeon
timeFrame: Up to 3 months
measure: Median Wound Inflammation Score (AIRE) Reported by Operating Physician
timeFrame: Up to 3 months post surgery
measure: Median Scar Assessment (POSAS) by Operating Surgeon
timeFrame: Up to 3 months post surgery
measure: Wound Cosmesis (MHCS) Score by Operating Physician
timeFrame: Up to 3 months post surgery
measure: Differences Between Patient and Surgeon Total POSAS Scores
timeFrame: 3 months post-operatively
measure: Median Overall Opinion Score Reported by Plastic Surgeons
timeFrame: Up to 3 months
measure: Median Scar Assessment (POSAS) by Plastic Surgeon
timeFrame: Up to 3 months post surgery
measure: Wound Cosmesis (MHCS) Score by Plastic Surgeon
timeFrame: Up to 3 months post surgery
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Josef Eichinger, MD
role: PRINCIPAL_INVESTIGATOR
References: