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Study closed by the Einstein IRB
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-Octyl Cyanoacrylate and mesh | Experimental | The wound will be closed with 2-Octyl Cyanoacrylate and a mesh |
|
| 2-Octyl Cyanoacrylate | Active Comparator | The wound will be closed with just 2-Octyl Cyanoacrylate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Wound Appearance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konrad Gruson, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jack D. Weiler Hospital-Division of Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22258770 | Background | 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. | |
| 27836404 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only 1 participant was enrolled into the study. In the interest of safeguarding the identity of this individual, demographic information is not being disclosed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 2-Octyl Cyanoacrylate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Only 1 participant was enrolled into the study. In the interest of safeguarding the identity of this individual, participant age is not being disclosed. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data was not collected/aggregated and therefore not analyzed. | Posted | During surgery (approximately 40 minutes) |
|
1-year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Konrad Gruson, MD | Montefiore Medical Center | 3475774412 | kgruson@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2019 | Jun 7, 2023 | Prot_SAP_000.pdf |
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* 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
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Sealed envelop determining which arm the participant is assigned to
|
| 2-Octyl Cyanoacrylate | Device | Incisions will be closed with 2-Octyl Cyanoacrylate after undergoing a Total shoulder arthroplasty |
|
|
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 | 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 |
| 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 |
| Superficial Infection | Number of wounds with superficial skin infections will be reported | At each follow up visit up to 3 months after surgery |
| Deep Wound Infection | 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 | Will report the number of wounds that require post operative intervention | At each follow up visit up to 3 months after surgery |
| 25600545 | 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. |
| 25284299 | 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. |
| 18472319 | 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. |
| 28844382 | 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. |
| 28989390 | 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. |
| 29444755 | 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. |
| 29066251 | 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. |
| 23114193 | 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. |
| 28438450 | 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. |
| 24379118 | 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. |
| 23613192 | 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. |
| 23018695 | 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. |
| 28598492 | 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. |
| 29641342 | 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. |
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 |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Only 1 participant was enrolled into the study. In the interest of safeguarding the identity of this individual, gender is not being disclosed. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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 |
|
| 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 | Data was not collected/aggregated and therefore not analyzed. | Posted | 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. | Data was not collected/aggregated and therefore not analyzed. | Posted | 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 | Data was not collected/aggregated and therefore not analyzed. | Posted | 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 | Data was not collected/aggregated and therefore not analyzed. | Posted | At first post operative visit |
|
|
| Secondary | Superficial Infection | Number of wounds with superficial skin infections will be reported | Data was not collected/aggregated and therefore not analyzed. | Posted | At each follow up visit up to 3 months after surgery |
|
|
| Secondary | Deep Wound Infection | Number of deep wound infections found will be reported | Data was not collected/aggregated and therefore not analyzed. | Posted | 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 | Data was not collected/aggregated and therefore not analyzed. | Posted | At each follow up visit up to 3 months after surgery |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
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