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
About this trial
This is an interventional other trial for Shoulder Arthritis focused on measuring prino, total shoulder arthroplasty, wound closure
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
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
NCT ID
NCT03899753
First Posted
February 17, 2019
Last Updated
June 7, 2023
Sponsor
Montefiore Medical Center
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:
PubMed Identifier
22258770
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.
Results Reference
background
PubMed Identifier
27836404
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.
Results Reference
background
PubMed Identifier
25600545
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.
Results Reference
background
PubMed Identifier
25284299
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.
Results Reference
background
PubMed Identifier
18472319
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.
Results Reference
background
PubMed Identifier
28844382
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.
Results Reference
background
PubMed Identifier
28989390
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.
Results Reference
background
PubMed Identifier
29444755
Citation
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.
Results Reference
background
PubMed Identifier
29066251
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.
Results Reference
background
PubMed Identifier
23114193
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.
Results Reference
background
PubMed Identifier
28438450
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.
Results Reference
background
PubMed Identifier
24379118
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.
Results Reference
background
PubMed Identifier
23613192
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.
Results Reference
background
PubMed Identifier
23018695
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.
Results Reference
background
PubMed Identifier
28598492
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.
Results Reference
background
PubMed Identifier
29641342
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.
Results Reference
background
Learn more about this trial
Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond
We'll reach out to this number within 24 hrs