Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond

Shoulder Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03899753
• Other study ID #: 2018-9370
• Status: Terminated
• Phase: N/A
• Start date: December 31, 2020
• Est. completion date: April 21, 2021

Study information

• Verified date: June 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 21, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Shoulder Arthritis
• Shoulder Arthropathy Associated With Other Conditions

Intervention

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

Locations

Country	Name	City	State
United States	Jack D. Weiler Hospital-Division of Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	During surgery (approximately 40 minutes)
Secondary	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	Immediately post surgery
Secondary	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.	At each follow up visit up to 3 months after surgery
Secondary	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	At each follow up visit up to 3 months after surgery
Secondary	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	At first post operative visit
Secondary	Superficial Infection	Number of wounds with superficial skin infections will be reported	At each follow up visit up to 3 months after surgery
Secondary	Deep Wound Infection	Number of deep wound infections found will be reported	At each follow up visit up to 3 months after surgery
Secondary	Number of Wounds That Require Post Operative Intervention	Will report the number of wounds that require post operative intervention	At each follow up visit up to 3 months after surgery