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Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond

Primary Purpose

Shoulder Arthritis, Shoulder Arthropathy Associated With Other Conditions

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2-Octyl Cyanoacrylate and Mesh
2-Octyl Cyanoacrylate
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Shoulder Arthritis focused on measuring prino, total shoulder arthroplasty, wound closure

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jack D. Weiler Hospital-Division of Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

2-Octyl Cyanoacrylate and mesh

2-Octyl Cyanoacrylate

Arm Description

The wound will be closed with 2-Octyl Cyanoacrylate and a mesh

The wound will be closed with just 2-Octyl Cyanoacrylate

Outcomes

Primary Outcome Measures

Time for Incision Closure
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

Cost of Closure
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
Wound Appearance
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
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
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
Superficial Infection
Number of wounds with superficial skin infections will be reported
Deep Wound Infection
Number of deep wound infections found will be reported
Number of Wounds That Require Post Operative Intervention
Will report the number of wounds that require post operative intervention

Full Information

First Posted
February 17, 2019
Last Updated
June 7, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03899753
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Study closed by the Einstein IRB
Study Start Date
December 31, 2020 (Actual)
Primary Completion Date
April 21, 2021 (Actual)
Study Completion Date
April 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Arthritis, Shoulder Arthropathy Associated With Other Conditions
Keywords
prino, total shoulder arthroplasty, wound closure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantInvestigator
Masking Description
Sealed envelop determining which arm the participant is assigned to
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2-Octyl Cyanoacrylate and mesh
Arm Type
Experimental
Arm Description
The wound will be closed with 2-Octyl Cyanoacrylate and a mesh
Arm Title
2-Octyl Cyanoacrylate
Arm Type
Active Comparator
Arm Description
The wound will be closed with just 2-Octyl Cyanoacrylate
Intervention Type
Device
Intervention Name(s)
2-Octyl Cyanoacrylate and Mesh
Other Intervention Name(s)
Prineo
Intervention Description
2-Octyl Cyanoacrylate and a mesh will be applied to final closure of wounds after undergoing a Total Shoulder Arthroplasty
Intervention Type
Device
Intervention Name(s)
2-Octyl Cyanoacrylate
Other Intervention Name(s)
Dermabond
Intervention Description
Incisions will be closed with 2-Octyl Cyanoacrylate after undergoing a Total shoulder arthroplasty
Primary Outcome Measure Information:
Title
Time for Incision Closure
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.
Time Frame
During surgery (approximately 40 minutes)
Secondary Outcome Measure Information:
Title
Cost of Closure
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
Time Frame
Immediately post surgery
Title
Wound Appearance
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.
Time Frame
At each follow up visit up to 3 months after surgery
Title
Dehiscence
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
Time Frame
At each follow up visit up to 3 months after surgery
Title
Wound Drainage
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
Time Frame
At first post operative visit
Title
Superficial Infection
Description
Number of wounds with superficial skin infections will be reported
Time Frame
At each follow up visit up to 3 months after surgery
Title
Deep Wound Infection
Description
Number of deep wound infections found will be reported
Time Frame
At each follow up visit up to 3 months after surgery
Title
Number of Wounds That Require Post Operative Intervention
Description
Will report the number of wounds that require post operative intervention
Time Frame
At each follow up visit up to 3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad Gruson, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jack D. Weiler Hospital-Division of Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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22258770
Citation
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Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond

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