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.
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.
Brief Title
Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond
Completion Date
Completion Date Type
Actual
Conditions
Shoulder Arthritis
Shoulder Arthropathy Associated With Other Conditions
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
* 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
Inclusion Criteria
Inclusion Criteria:
* Total shoulder arthroplasty
* Reverse total shoulder arthroplasty
* Age 18-100
* Single Surgeon
* Total shoulder arthroplasty
* Reverse total shoulder arthroplasty
* Age 18-100
* Single Surgeon
Gender
All
Gender Based
false
Keywords
prino
total shoulder arthroplasty
wound closure
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
100 Years
Minimum Age
18 Years
NCT Id
NCT03899753
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2018-9370
Overall Status
Terminated
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Closure After Total Shoulder Arthroplasty: Subcuticular Closure With 2-Octyl Cyanoacrylate Versus 2-Octyl Cyanoacrylate With A Self-Adhering Mesh (Dermabond Prineo)
Primary Outcomes
Outcome Description
A stopwatch will be used to measure the time it takes for the incision to be closed. When the surgical implants are in place and irrigation is complete, the surgeon will announce that he will start the closure and a nurse will start the stopwatch to measure how long it takes for the surgeon to close the incision.
Outcome Measure
Time for Incision Closure
Outcome Time Frame
During surgery (approximately 40 minutes)
Secondary Outcomes
Outcome Description
Cost of closure will be assessed by the cost of the time in the operating room and the cost of materials used to close the incision
Outcome Time Frame
Immediately post surgery
Outcome Measure
Cost of Closure
Outcome Description
The surgeon and participant will fill out the Patient and Observer Scar Assessment Scale (POSAS). This is a survey used to assess the participant and the surgeons opinion of the appearance of the wound. The Patient and Observer Scar Assessment Scale (POSAS) is a questionnaire that was developed to assess scar quality. It consists of two separate six-item scales (Observer Scale and Patient Scale), both of which are scored on a 10-point rating scale. Each questionnaire consists of 7 questions, each graded 1 through 10. The minimum score is 7 (most like normal skin) and the maximum score is 70 (very different from normal skin). The observer is the surgeon. The observer and patient scores can then be added together to determine the collective score.
Outcome Time Frame
At each follow up visit up to 3 months after surgery
Outcome Measure
Wound Appearance
Outcome Description
The wound will be assessed for dehiscence (incision opening) which will be recorded as a "yes or no". A dehiscence is defined as exposure of the underlying subcutaneous fat secondary to failure of the epidermal healing and may be accompanied by persistent wound drainage. It will be assessed by the length of the opening in centimeters and then normalized against the length of the entire incision. Furthermore, the number of wounds that open will be reported
Outcome Time Frame
At each follow up visit up to 3 months after surgery
Outcome Measure
Dehiscence
Outcome Description
Dressing for each participant after surgery will be regulated and changed by the surgeon at the first post op visit. Drainage will be measured by outlining the drainage on gauze onto graph paper and measuring the area as previously validated in prior studies
Outcome Time Frame
At first post operative visit
Outcome Measure
Wound Drainage
Outcome Description
Number of wounds with superficial skin infections will be reported
Outcome Time Frame
At each follow up visit up to 3 months after surgery
Outcome Measure
Superficial Infection
Outcome Description
Number of deep wound infections found will be reported
Outcome Time Frame
At each follow up visit up to 3 months after surgery
Outcome Measure
Deep Wound Infection
Outcome Description
Will report the number of wounds that require post operative intervention
Outcome Time Frame
At each follow up visit up to 3 months after surgery
Outcome Measure
Number of Wounds That Require Post Operative Intervention
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
100
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Konrad Gruson
Investigator Email
kgruson@montefiore.org
Investigator Phone