Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03899753

Enrollment

Registered

2019-04-02

Start date

2020-12-31

Completion date

2021-04-21

Last updated

2023-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Arthritis, Shoulder Arthropathy Associated With Other Conditions

Keywords

prino, total shoulder arthroplasty, wound closure

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.

Interventions

DEVICE2-Octyl Cyanoacrylate and Mesh

2-Octyl Cyanoacrylate and a mesh will be applied to final closure of wounds after undergoing a Total Shoulder Arthroplasty

DEVICE2-Octyl Cyanoacrylate

Incisions will be closed with 2-Octyl Cyanoacrylate after undergoing a Total shoulder arthroplasty

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Masking description

Sealed envelop determining which arm the participant is assigned to

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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
Deep Wound Infection	At each follow up visit up to 3 months after surgery	Number of deep wound infections found will be reported
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
Superficial Infection	At each follow up visit up to 3 months after surgery	Number of wounds with superficial skin infections will be reported

Countries

United States

Participant flow

Participants by arm

Arm	Count
2-Octyl Cyanoacrylate and Mesh The wound will be closed with 2-Octyl Cyanoacrylate and a mesh 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	1
2-Octyl Cyanoacrylate The wound will be closed with just 2-Octyl Cyanoacrylate 2-Octyl Cyanoacrylate: Incisions will be closed with 2-Octyl Cyanoacrylate after undergoing a Total shoulder arthroplasty	0
Total	1

Baseline characteristics

Characteristic	2-Octyl Cyanoacrylate and Mesh	Total
Age, Categorical <=18 years	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants
Race and Ethnicity Not Collected	—	0 Participants
Region of Enrollment United States	1 participants	1 participants
Sex: Female, Male Female	—	0 Participants
Sex: Female, Male Male	—	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

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.

Time frame: During surgery (approximately 40 minutes)