Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond

Not Applicable

Terminated

Conditions: Shoulder Arthropathy Associated With Other Conditions
Shoulder Arthritis

Interventions: Device: 2-Octyl Cyanoacrylate and Mesh
Device: 2-Octyl Cyanoacrylate

Registration Number: NCT03899753

Lead Sponsor: Montefiore Medical Center

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2-Octyl Cyanoacrylate and mesh	2-Octyl Cyanoacrylate and Mesh	The wound will be closed with 2-Octyl Cyanoacrylate and a mesh
2-Octyl Cyanoacrylate	2-Octyl Cyanoacrylate	The wound will be closed with just 2-Octyl Cyanoacrylate

Primary Outcome Measures

Name	Time	Method
Time for Incision Closure	During surgery (approximately 40 minutes)	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.

Secondary Outcome Measures

Name	Time	Method
Superficial Infection	At each follow up visit up to 3 months after surgery	Number of wounds with superficial skin infections will be reported
Cost of Closure	Immediately post surgery	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
Number of Wounds That Require Post Operative Intervention	At each follow up visit up to 3 months after surgery	Will report the number of wounds that require post operative intervention
Wound Appearance	At each follow up visit up to 3 months after surgery	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.
Dehiscence	At each follow up visit up to 3 months after surgery	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
Wound Drainage	At first post operative visit	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
Deep Wound Infection	At each follow up visit up to 3 months after surgery	Number of deep wound infections found will be reported