Clinical trial NCT03899753: Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond
Official title: Closure After Total Shoulder Arthroplasty: Subcuticular Closure With 2-Octyl Cyanoacrylate Versus 2-Octyl Cyanoacrylate With A Self-Adhering Mesh (Dermabond Prineo)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Shoulder Arthritis
Shoulder Arthropathy Associated With Other Conditions
Keywords: prino
total shoulder arthroplasty
wound closure
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: \* Prospective Randomized Design

o After determining a participant's eligibility for inclusion, participant will be randomized to the OCA mesh group or monocryl with dermabond group. After surgery, both groups will be seen at the 2 week, 6 week, and 3 month appointments
Primary purpose: OTHER

Brief summary: The objective is to compare two types of wound closure after total shoulder arthroplasty to determine which closure is faster, and subsequently if there are different outcomes between the two types of closures.

The objective of this study is to compare two types of wound closure after total shoulder arthroplasty procedures. A single fellowship trained shoulder surgeon will perform all procedures. It is hypothesized that participants who undergo an 2-Octyl Cyanoacrylate (OCA) mesh closure will have a faster closure time, lower cost, non-inferior complication rate, and non-inferior satisfaction scores with respect postoperative follow up and scar appearance.

Participants in the OCA mesh cohort will be compared to participants who have a closure with a running monocryl suture and dermabond. This investigation seeks to determine if OCA closure mesh closure is non-inferior to monocryl suture and dermabond in terms of operative time, cost, complications, and aesthetic appearance.

If the hypothesis is confirmed, this study will suggest that a OCA mesh closure may be used for total shoulder arthroplasty surgeries as an alternative to current conventional closures and may provide a cost benefit.


Eligibility criteria: Inclusion Criteria:

* Total shoulder arthroplasty
* Reverse total shoulder arthroplasty
* Age 18-100
* Single Surgeon

Exclusion Criteria:

* Previous shoulder surgery
* Known wound healing complications
* DM, chronic steroid use, vascular insufficiency, morbid obesity (BMI\>40), ESRD, family hx of pathologic scars
* Patients on blood thinners (ASA 81mg ok)
* Connective tissue disease
* Allergy to skin adhesive
* Mentally unable to complete questionnaires
* Previous wound over planned incision

Primary outcomes:
measure: Time for Incision Closure
timeFrame: During surgery (approximately 40 minutes)
Secondary outcomes:
measure: Cost of Closure
timeFrame: Immediately post surgery
measure: Wound Appearance
timeFrame: At each follow up visit up to 3 months after surgery
measure: Dehiscence
timeFrame: At each follow up visit up to 3 months after surgery
measure: Wound Drainage
timeFrame: At first post operative visit
measure: Superficial Infection
timeFrame: At each follow up visit up to 3 months after surgery
measure: Deep Wound Infection
timeFrame: At each follow up visit up to 3 months after surgery
measure: Number of Wounds That Require Post Operative Intervention
timeFrame: At each follow up visit up to 3 months after surgery
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jack D. Weiler Hospital-Division of Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Konrad Gruson, MD
role: PRINCIPAL_INVESTIGATOR
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