Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond

June 7, 2023 updated by: Montefiore Medical Center

Closure After Total Shoulder Arthroplasty: Subcuticular Closure With 2-Octyl Cyanoacrylate Versus 2-Octyl Cyanoacrylate With A Self-Adhering Mesh (Dermabond Prineo)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Jack D. Weiler Hospital-Division of Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2-Octyl Cyanoacrylate and mesh
The wound will be closed with 2-Octyl Cyanoacrylate and a mesh
Device: 2-Octyl Cyanoacrylate and Mesh
2-Octyl Cyanoacrylate and a mesh will be applied to final closure of wounds after undergoing a Total Shoulder Arthroplasty
Other Names:
  • Prineo
Active Comparator: 2-Octyl Cyanoacrylate
The wound will be closed with just 2-Octyl Cyanoacrylate
Device: 2-Octyl Cyanoacrylate
Incisions will be closed with 2-Octyl Cyanoacrylate after undergoing a Total shoulder arthroplasty
Other Names:
  • Dermabond

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time for Incision Closure
Time Frame: 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.
During surgery (approximately 40 minutes)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Konrad Gruson, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2020

Primary Completion (Actual)

April 21, 2021

Study Completion (Actual)

April 21, 2021

Study Registration Dates

First Submitted

February 17, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-9370

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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