Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond

NCT03899753 | Terminated Results FDA Device

• 1 other identifier: 2018-9370
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Arthritis; Shoulder Arthropathy Associated With Other Conditions

Keywords

prino; total shoulder arthroplasty; wound closure

Outcome Measures

Primary Outcomes (1)

• 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.

  During surgery (approximately 40 minutes)

Secondary Outcomes (7)

• Cost of Closure

  Immediately post surgery

• Wound Appearance

  At each follow up visit up to 3 months after surgery

• Dehiscence

  At each follow up visit up to 3 months after surgery

• Wound Drainage

  At first post operative visit

• Superficial Infection

  At each follow up visit up to 3 months after surgery

Study Arms (2)

2-Octyl Cyanoacrylate and mesh

EXPERIMENTAL

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

Device: 2-Octyl Cyanoacrylate and Mesh

2-Octyl Cyanoacrylate

ACTIVE COMPARATOR

The wound will be closed with just 2-Octyl Cyanoacrylate

Device: 2-Octyl Cyanoacrylate

Interventions

2-Octyl Cyanoacrylate and Mesh DEVICE

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

Also known as: Prineo

2-Octyl Cyanoacrylate and mesh

2-Octyl Cyanoacrylate DEVICE

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

Also known as: Dermabond

2-Octyl Cyanoacrylate

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total shoulder arthroplasty
• Reverse total shoulder arthroplasty
• Age 18-100
• Single Surgeon

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Jack D. Weiler Hospital-Division of Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (16)

• Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011 Dec 21;93(24):2249-54. doi: 10.2106/JBJS.J.01994.

  PMID: 22258770 BACKGROUND

• Martin JG, Hollenbeck ST, Janas G, Makar RA, Pabon-Ramos WM, Suhocki PV, Miller MJ, Sopko DR, Smith TP, Kim CY. Randomized Controlled Trial of Octyl Cyanoacrylate Skin Adhesive versus Subcuticular Suture for Skin Closure after Implantable Venous Port Placement. J Vasc Interv Radiol. 2017 Jan;28(1):111-116. doi: 10.1016/j.jvir.2016.08.009. Epub 2016 Nov 9.

  PMID: 27836404 BACKGROUND

• Grimaldi L, Cuomo R, Brandi C, Botteri G, Nisi G, D'Aniello C. Octyl-2-cyanoacrylate adhesive for skin closure: eight years experience. In Vivo. 2015 Jan-Feb;29(1):145-8.

  PMID: 25600545 BACKGROUND

• Imbuldeniya AM, Rashid A, Murphy JP. A comparison of 2-octyl cyanoacrylate with nylon for wound closure of knee arthroscopy portals. J Wound Care. 2014 Sep;23(9):456-8, 460. doi: 10.12968/jowc.2014.23.9.456.

  PMID: 25284299 BACKGROUND

• Freitas-Junior R, Paulinelli RR, Rahal RM, Moreira MA, Oliveira EL, Aiko KF, Approbato MS. The use of 2-octyl cyanoacrylate or nylon suture for skin closure produces similar modifications in scar tissue (an animal model). J Plast Reconstr Aesthet Surg. 2008 Aug;61(8):990-2. doi: 10.1016/j.bjps.2007.11.052. Epub 2008 May 9. No abstract available.

  PMID: 18472319 BACKGROUND

• Prince D, Solanki Z, Varughese R, Mastej J, Prince D. Antibacterial effect and proposed mechanism of action of a topical surgical adhesive. Am J Infect Control. 2018 Jan;46(1):26-29. doi: 10.1016/j.ajic.2017.07.008. Epub 2017 Aug 24.

  PMID: 28844382 BACKGROUND

• Rushbrook JL, White G, Kidger L, Marsh P, Taggart TF. The antibacterial effect of 2-octyl cyanoacrylate (Dermabond(R)) skin adhesive. J Infect Prev. 2014 Nov;15(6):236-239. doi: 10.1177/1757177414551562. Epub 2014 Nov 30.

  PMID: 28989390 BACKGROUND

• Clark JJC, Abildgaard JT, Backes J, Hawkins RJ. Preventing infection in shoulder surgery. J Shoulder Elbow Surg. 2018 Jul;27(7):1333-1341. doi: 10.1016/j.jse.2017.12.028. Epub 2018 Feb 12.

  PMID: 29444755 BACKGROUND

• Krebs VE, Elmallah RK, Khlopas A, Chughtai M, Bonutti PM, Roche M, Mont MA. Wound Closure Techniques for Total Knee Arthroplasty: An Evidence-Based Review of the Literature. J Arthroplasty. 2018 Feb;33(2):633-638. doi: 10.1016/j.arth.2017.09.032. Epub 2017 Sep 25.

  PMID: 29066251 BACKGROUND

• El-Gazzar Y, Smith DC, Kim SJ, Hirsh DM, Blum Y, Cobelli M, Cohen HW. The use of dermabond(R) as an adjunct to wound closure after total knee arthroplasty: examining immediate post-operative wound drainage. J Arthroplasty. 2013 Apr;28(4):553-6. doi: 10.1016/j.arth.2012.07.038. Epub 2012 Oct 29.

  PMID: 23114193 BACKGROUND

• Glennie RA, Korczak A, Naudie DD, Bryant DM, Howard JL. MONOCRYL and DERMABOND vs Staples in Total Hip Arthroplasty Performed Through a Lateral Skin Incision: A Randomized Controlled Trial Using a Patient-Centered Assessment Tool. J Arthroplasty. 2017 Aug;32(8):2431-2435. doi: 10.1016/j.arth.2017.02.042. Epub 2017 Feb 24.

  PMID: 28438450 BACKGROUND

• Mudd CD, Boudreau JA, Moed BR. A prospective randomized comparison of two skin closure techniques in acetabular fracture surgery. J Orthop Traumatol. 2014 Sep;15(3):189-94. doi: 10.1007/s10195-013-0282-7. Epub 2013 Dec 31.

  PMID: 24379118 BACKGROUND

• Parvizi D, Friedl H, Schintler MV, Rappl T, Laback C, Wiedner M, Vasiljeva A, Kamolz LP, Spendel S. Use of 2-octyl cyanoacrylate together with a self-adhering mesh (Dermabond Prineo) for skin closure following abdominoplasty: an open, prospective, controlled, randomized, clinical study. Aesthetic Plast Surg. 2013 Jun;37(3):529-37. doi: 10.1007/s00266-013-0123-3. Epub 2013 Apr 24.

  PMID: 23613192 BACKGROUND

• Richter D, Stoff A, Ramakrishnan V, Exner K, Jernbeck J, Blondeel PN. A comparison of a new skin closure device and intradermal sutures in the closure of full-thickness surgical incisions. Plast Reconstr Surg. 2012 Oct;130(4):843-850. doi: 10.1097/PRS.0b013e318262f237.

  PMID: 23018695 BACKGROUND

• Holte AJ, Tofte JN, Dahlberg GJ, Noiseux N. Use of 2-Octyl Cyanoacrylate Adhesive and Polyester Mesh for Wound Closure in Primary Knee Arthroplasty. Orthopedics. 2017 Sep 1;40(5):e784-e787. doi: 10.3928/01477447-20170531-03. Epub 2017 Jun 9.

  PMID: 28598492 BACKGROUND

• Sutton N, Schmitz ND, Johnston SS. Economic and clinical comparison of 2-octyl cyanoacrylate/polymer mesh tape with skin staples in total knee replacement. J Wound Care. 2018 Apr 1;27(Sup4):S12-S22. doi: 10.12968/jowc.2018.27.Sup4.S12.

  PMID: 29641342 BACKGROUND

Limitations and Caveats

Only 1 participant was enrolled into the study. In the interest of safeguarding the identity of the individual, demographic information is not being disclosed. Data was not collected/aggregated and therefore not analyzed.

Results Point of Contact

• Title: Konrad Gruson, MD
• Organization: Montefiore Medical Center

kgruson@montefiore.org

3475774412

Study Officials

• Konrad Gruson, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sealed envelop determining which arm the participant is assigned to
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: \* 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

Study Record Dates

• First Submitted: February 17, 2019
• First Posted: April 2, 2019
• Study Start: December 31, 2020
• Primary Completion: April 21, 2021
• Study Completion: April 21, 2021
• Last Updated: July 3, 2023
• Results First Posted: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)