OsteoArthritis Knee Clinical Trial
Official title:
A Comparison of 2-octyl Cyanoacrylate Skin Adhesive and Polyester Mesh for Wound Closure in Total Knee Arthroplasty, A Randomized Controlled Study
Verified date | June 2024 |
Source | HatYai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | December 1, 2024 |
Est. primary completion date | September 28, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility | Inclusion Criteria: - OA knee need for Total knee arthroplasty - Age 50-80 years old Exclusion Criteria: - Previous surgery of knee - History of Keloid, Scar, Psoriasis at the knee - History of contact dermatitis with skin adhesive - Cognitive impairment |
Country | Name | City | State |
---|---|---|---|
Thailand | Pooriwat Lertsurawat | Songkhla |
Lead Sponsor | Collaborator |
---|---|
Pooriwat Lertsurawat | Kittipon Naratrikun |
Thailand,
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. — 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
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum In: Eur J Orthop Surg Traumatol. 2020 Mar 31;: — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient observer scar assessment score (POSAS) | Evaluated Patient observer scar assessment score (POSAS)
The POSAS is composed of two numerical scales that evaluate signs and symptoms of healing. Consists of the two following parts: a scale for patients and a scale for observers. Both contain six items punctuated numerically from 1 to 10 The lowest score is 1 and corresponds to the normal skin The highest score is 10 and corresponds to the worst skin The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60. |
6 weeks, 3 months | |
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, height, pliability, and pigmentation 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 10 and corresponds to the worst skin. |
6weeks, 3 months | |
Secondary | Wound complication | Evaluated wound complication ( Wound dehiscence Superficial wound infection Allergic contact dermatitis)
Outcome Measure reported as number of patients had developed wound complication within 3 months follow up and calculated proportion of wound complication in percentage |
Within 3 months | |
Secondary | Wound drainage | Evaluated by Count table of blood strike on Water proof dressing
Outcome Measure by Count number of blood strike on water proof dressing by put the water proof dressing on the table grid square millimeter and count blood strike Reported as Number of blood strike as square millimeter |
2 weeks |
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