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| Name | Class |
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| Kittipon Naratrikun | UNKNOWN |
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The goal of this randomized controlled study is to investigate the Efficacy of Using skin adhesive (Dermabond) and skin adhesive with polyester mesh (Dermabond Prineo )for Wound Closure in Total Knee Arthroplasty, The main question it aim to answer
1 Are skin adhesive alone and with Polyester mesh in Total knee arthroplasty different in Patient satisfaction evaluated by POSAS score
Nowadays, there are many methods of wound closure in Total Knee arthroplasty, such as nylon, skin staple, and sterile strip, which differ in advantages and disadvantages of each technique. However, these methods have the same disadvantages: wound discharge, which may lead to infection, wound separation, and the need for wound dressing. It is also a burden for patients and caregivers. In travelling to change the wound in a hospital, There are many costs in terms of wound dressing equipment, travel costs and time off from work for caregivers to take patients to get wound dressing.
Skin adhesive is an innovation for wound closure in total knee arthroplasty. It reduces the problem of wound separation, with no need for wound dressing.
Skin adhesive mesh has been studied in many studies, showing that it can be used well. Strong It is no different from traditional wound closure; the scar is more beautiful. Patients are more satisfied. But the disadvantage is the high price.
Skin adhesive without polyester mesh has the advantage of being cheaper three times than polyester mesh but less intense than with mesh. This makes it unpopular.
No studies have been found comparing wound dressings with mesh and no mesh After knee replacement surgery.
Therefore, this study is to compare skin adhesive and skin adhesive plus polyester mesh in closure wound total knee arthroplasty.
Are there differences in patient satisfaction Are wound complications such as wound oozing, wound separation, superficial wound skin infection, and contact dermatitis different?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin adhesive | Experimental | 2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson & johnson, Somerville, NJ) |
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| skin adhesive Plus polyester mesh | Active Comparator | 2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson & johnson, Somerville, NJ) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin adhesive (Dermabond) | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Observer Scar Assessment Score (POSAS) | Evaluated Patient observer scar assessment score (POSAS)
| 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Observer Scar Assessment Score (POSAS) | Evaluated Patient observer scar assessment score (POSAS)
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pooriwat Lertsurawat | Songkhla | Changwat Songkhla | 90110 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32922017 | Background | Kong X, Yang M, Guo R, Chen J, Chai W, Wang Y. A Prospective, Randomized and Controlled Study on Tissue Adhesive for Skin Incision in Total Knee Arthroplasty. Ther Clin Risk Manag. 2020 Aug 24;16:795-802. doi: 10.2147/TCRM.S260007. eCollection 2020. | |
| 31691153 | Background | Sundaram K, Piuzzi NS, Patterson BM, Stearns KL, Krebs VE, Mont MA. Skin closure with 2-octyl cyanoacrylate and polyester mesh after primary total knee arthroplasty offers superior cosmetic outcomes and patient satisfaction compared to staples: a prospective trial. Eur J Orthop Surg Traumatol. 2020 Apr;30(3):447-453. doi: 10.1007/s00590-019-02591-4. Epub 2019 Nov 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Skin Adhesive | 2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson & johnson, Somerville, NJ) Skin adhesive (Dermabond): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson & johnson, Somerville, NJ)
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Oct 11, 2023 |
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| skin adhesive + polyester mesh (Dermabond prineo) | Device |
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| 3 months |
| Vancouver Scar Scale | Evaluated vancouver scar scale Vancouver Scar Scale (VSS) is used for validated scar assessment tools. Consist of the four following parts: vascularity(0-3) , height(0-3), pliability(0-5), and pigmentation(0-2). Each characteristic is given a score, which are added together to give an overall score between 0 and 13. The lowest score is 0 and corresponds to the normal skin. The highest score is 13 and corresponds to the worst skin. | 6 weeks |
| Wound Leakage | Wound leakage was evaluated by measuring the total blood-stained area on the waterproof dressing. The dressing was placed on a standardized 1 mm² grid, and the stained area was calculated in square millimeters (mm²). | 2 weeks |
| Vancouver Scar Scale | Evaluated vancouver scar scale Vancouver Scar Scale (VSS) is used for validated scar assessment tools. Consist of the four following parts: vascularity(0-3) , height(0-3), pliability(0-5), and pigmentation(0-2). Each characteristic is given a score, which are added together to give an overall score between 0 and 13. The lowest score is 0 and corresponds to the normal skin. The highest score is 13 and corresponds to the worst skin. | 3 months |
| 34024693 | Background | Choi KY, Koh IJ, Kim MS, Park DC, Sung YG, In Y. 2-Octyl Cyanoacrylate Topical Adhesive as an Alternative to Subcuticular Suture for Skin Closure After Total Knee Arthroplasty: A Randomized Controlled Trial in the Same Patient. J Arthroplasty. 2021 Sep;36(9):3141-3147. doi: 10.1016/j.arth.2021.04.033. Epub 2021 May 3. |
| 16434531 | Background | Khan RJ, Fick D, Yao F, Tang K, Hurworth M, Nivbrant B, Wood D. A comparison of three methods of wound closure following arthroplasty: a prospective, randomised, controlled trial. J Bone Joint Surg Br. 2006 Feb;88(2):238-42. doi: 10.1302/0301-620X.88B2.16923. |
| 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. |
| 30811354 | Background | Gromov K, Troelsen A, Raaschou S, Sandhold H, Nielsen CS, Kehlet H, Husted H. Tissue Adhesive for Wound Closure Reduces Immediate Postoperative Wound Dressing Changes After Primary TKA: A Randomized Controlled Study in Simultaneous Bilateral TKA. Clin Orthop Relat Res. 2019 Sep;477(9):2032-2038. doi: 10.1097/CORR.0000000000000637. |
| 28487090 | Background | Kim KY, Anoushiravani AA, Long WJ, Vigdorchik JM, Fernandez-Madrid I, Schwarzkopf R. A Meta-Analysis and Systematic Review Evaluating Skin Closure After Total Knee Arthroplasty-What Is the Best Method? J Arthroplasty. 2017 Sep;32(9):2920-2927. doi: 10.1016/j.arth.2017.04.004. Epub 2017 Apr 12. |
| FG001 | Skin Adhesive Plus Polyester Mesh | 2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson & johnson, Somerville, NJ) skin adhesive + polyester mesh (Dermabond prineo): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson & johnson, Somerville, NJ)
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Skin Adhesive | 2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson & johnson, Somerville, NJ) Skin adhesive (Dermabond): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson & johnson, Somerville, NJ)
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| BG001 | Skin Adhesive Plus Polyester Mesh | 2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson & johnson, Somerville, NJ) skin adhesive + polyester mesh (Dermabond prineo): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson & johnson, Somerville, NJ)
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| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | Kg/m2 |
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| Hypertension | Number | participants |
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| Diabetic mellitus | Number | participants |
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| Dyslipidemia | Number | participants |
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| Smoking | Number | participants |
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| Alcohol | Number | participants |
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| 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 | Patient Observer Scar Assessment Score (POSAS) | Evaluated Patient observer scar assessment score (POSAS)
| Posted | Median | Inter-Quartile Range | score on a scale | 6 weeks |
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| Secondary | Patient Observer Scar Assessment Score (POSAS) | Evaluated Patient observer scar assessment score (POSAS)
| Posted | Median | Inter-Quartile Range | score on a scale | 3 months |
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| Secondary | Vancouver Scar Scale | Evaluated vancouver scar scale Vancouver Scar Scale (VSS) is used for validated scar assessment tools. Consist of the four following parts: vascularity(0-3) , height(0-3), pliability(0-5), and pigmentation(0-2). Each characteristic is given a score, which are added together to give an overall score between 0 and 13. The lowest score is 0 and corresponds to the normal skin. The highest score is 13 and corresponds to the worst skin. | Posted | Median | Inter-Quartile Range | Score (0-13) | 6 weeks |
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| Secondary | Wound Leakage | Wound leakage was evaluated by measuring the total blood-stained area on the waterproof dressing. The dressing was placed on a standardized 1 mm² grid, and the stained area was calculated in square millimeters (mm²). | Posted | Median | Inter-Quartile Range | square millimeter (mm²) | 2 weeks |
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| Secondary | Vancouver Scar Scale | Evaluated vancouver scar scale Vancouver Scar Scale (VSS) is used for validated scar assessment tools. Consist of the four following parts: vascularity(0-3) , height(0-3), pliability(0-5), and pigmentation(0-2). Each characteristic is given a score, which are added together to give an overall score between 0 and 13. The lowest score is 0 and corresponds to the normal skin. The highest score is 13 and corresponds to the worst skin. | Posted | Median | Inter-Quartile Range | Score (0-13) | 3 months |
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From 2 weeks to 12 weeks
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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 | Skin Adhesive | 2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson & johnson, Somerville, NJ) | 0 | 40 | 0 | 40 | 1 | 40 |
| EG001 | Skin Adhesive Plus Polyester Mesh | 2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson & johnson, Somerville, NJ) | 0 | 38 | 0 | 38 | 4 | 38 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic contact dermatitis | Surgical and medical procedures | Non-systematic Assessment | Mild erythema and itching at wound area, resolved with topical treatment. |
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This study has several limitations. First, it is a single-center design, so it may restrict the generalizability of our findings to other institutions and patient populations Second, all procedures were done by one experienced hip and knee arthroplasty surgeon, who had an individual technique that could have influenced wound closure quality Third, our primary outcome was the Patient and Observer which relies on patient and research assessor and may have some bias
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pooriwat Lertsurawat | Hatyai hospital | 087-6329824 | Pooriwat999@gmail.com |
| Dec 12, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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