Nctid:
NCT06232018
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D020370", "term"=>"Osteoarthritis, Knee"}], "ancestors"=>[{"id"=>"D010003", "term"=>"Osteoarthritis"}, {"id"=>"D001168", "term"=>"Arthritis"}, {"id"=>"D007592", "term"=>"Joint Diseases"}, {"id"=>"D009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D012216", "term"=>"Rheumatic Diseases"}], "browseLeaves"=>[{"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}, {"id"=>"M12926", "name"=>"Osteoarthritis", "relevance"=>"LOW"}, {"id"=>"M22168", "name"=>"Osteoarthritis, Knee", "asFound"=>"Osteoarthritis Knee", "relevance"=>"HIGH"}, {"id"=>"M4476", "name"=>"Arthritis", "relevance"=>"LOW"}, {"id"=>"M10621", "name"=>"Joint Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M15045", "name"=>"Rheumatic Diseases", "relevance"=>"LOW"}, {"id"=>"M6323", "name"=>"Collagen Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>80}}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2023-09-28", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-06", "completionDateStruct"=>{"date"=>"2024-12-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-06-07", "studyFirstSubmitDate"=>"2024-01-20", "studyFirstSubmitQcDate"=>"2024-01-20", "lastUpdatePostDateStruct"=>{"date"=>"2024-06-11", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-09-28", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Patient observer scar assessment score (POSAS)", "timeFrame"=>"6 weeks, 3 months", "description"=>"Evaluated Patient observer scar assessment score (POSAS)\n\n* The POSAS is composed of two numerical scales that evaluate signs and symptoms of healing.\n* Consists of the two following parts: a scale for patients and a scale for observers.\n* Both contain six items punctuated numerically from 1 to 10\n* The lowest score is 1 and corresponds to the normal skin\n* The highest score is 10 and corresponds to the worst skin\n* The total score of both scales can be calculated simply by adding the scores of each of the six items.\n* The total score will range from 6 to 60."}], "secondaryOutcomes"=>[{"measure"=>"Vancouver scar scale", "timeFrame"=>"6weeks, 3 months", "description"=>"Evaluated vancouver scar scale\n\n* Vancouver Scar Scale (VSS) is used for validated scar assessment tools\n* Consist of the four following parts : vascularity, height, pliability, and pigmentation\n* Each characteristic is given a score, which are added together to give an overall score between 0 and 13\n* The lowest score is 0 and corresponds to the normal skin.\n* The highest score is 10 and corresponds to the worst skin."}, {"measure"=>"Wound complication", "timeFrame"=>"Within 3 months", "description"=>"Evaluated wound complication ( Wound dehiscence Superficial wound infection Allergic contact dermatitis)\n\nOutcome Measure reported as number of patients had developed wound complication within 3 months follow up and calculated proportion of wound complication in percentage"}, {"measure"=>"Wound drainage", "timeFrame"=>"2 weeks", "description"=>"Evaluated by Count table of blood strike on Water proof dressing\n\nOutcome 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"}]}, "oversightModule"=>{"isUsExport"=>true, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"keywords"=>["Dermabond", "Dermabond prineo"], "conditions"=>["OsteoArthritis Knee"]}, "referencesModule"=>{"references"=>[{"pmid"=>"32922017", "type"=>"BACKGROUND", "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."}, {"pmid"=>"31691153", "type"=>"BACKGROUND", "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 Apr;30(3):455-456. doi: 10.1007/s00590-020-02632-3."}, {"pmid"=>"34024693", "type"=>"BACKGROUND", "citation"=>"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."}, {"pmid"=>"16434531", "type"=>"BACKGROUND", "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."}, {"pmid"=>"23114193", "type"=>"BACKGROUND", "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."}, {"pmid"=>"30811354", "type"=>"BACKGROUND", "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."}, {"pmid"=>"28487090", "type"=>"BACKGROUND", "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."}]}, "descriptionModule"=>{"briefSummary"=>"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\n\n1 Are skin adhesive alone and with Polyester mesh in Total knee arthroplasty different in Patient satisfaction evaluated by POSAS score", "detailedDescription"=>"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.\n\nSkin adhesive is an innovation for wound closure in total knee arthroplasty. It reduces the problem of wound separation, with no need for wound dressing.\n\nSkin 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.\n\nSkin 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.\n\nNo studies have been found comparing wound dressings with mesh and no mesh After knee replacement surgery.\n\nTherefore, this study is to compare skin adhesive and skin adhesive plus polyester mesh in closure wound total knee arthroplasty.\n\nAre there differences in patient satisfaction Are wound complications such as wound oozing, wound separation, superficial wound skin infection, and contact dermatitis different?"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"50 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* OA knee need for Total knee arthroplasty\n* Age 50-80 years old\n\nExclusion Criteria:\n\n* Previous surgery of knee\n* History of Keloid, Scar, Psoriasis at the knee\n* History of contact dermatitis with skin adhesive\n* Cognitive impairment"}, "identificationModule"=>{"nctId"=>"NCT06232018", "briefTitle"=>"A Comparison of 2-octyl Cyanoacrylate Skin Adhesive and Polyester Mesh for Wound Closure in Total Knee Arthroplasty, A Randomized Controlled Study", "organization"=>{"class"=>"OTHER", "fullName"=>"HatYai Hospital"}, "officialTitle"=>"A Comparison of 2-octyl Cyanoacrylate Skin Adhesive and Polyester Mesh for Wound Closure in Total Knee Arthroplasty, A Randomized Controlled Study", "orgStudyIdInfo"=>{"id"=>"HYH EC 059-66-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Skin adhesive", "description"=>"2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \\& johnson, Somerville, NJ)", "interventionNames"=>["Device: Skin adhesive (Dermabond)"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"skin adhesive Plus polyester mesh", "description"=>"2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \\& johnson, Somerville, NJ)", "interventionNames"=>["Device: skin adhesive + polyester mesh (Dermabond prineo)"]}], "interventions"=>[{"name"=>"Skin adhesive (Dermabond)", "type"=>"DEVICE", "description"=>"* Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \\& johnson, Somerville, NJ)\n* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \\& johnson, Somerville, NJ)\n* After subticular sutures was done\n* 2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \\& johnson, Somerville, NJ) was applied", "armGroupLabels"=>["Skin adhesive"]}, {"name"=>"skin adhesive + polyester mesh (Dermabond prineo)", "type"=>"DEVICE", "description"=>"* Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \\& johnson, Somerville, NJ)\n* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \\& johnson, Somerville, NJ)\n* After subticular sutures was done\n* 2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \\& johnson, Somerville, NJ) was applied", "armGroupLabels"=>["skin adhesive Plus polyester mesh"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90110", "city"=>"Songkhla", "country"=>"Thailand", "facility"=>"Pooriwat Lertsurawat", "geoPoint"=>{"lat"=>7.19882, "lon"=>100.5951}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Pooriwat Lertsurawat", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Kittipon Naratrikun", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Resident Orthopedic of Hatyai Hospital", "investigatorFullName"=>"Pooriwat Lertsurawat", "investigatorAffiliation"=>"HatYai Hospital"}}}}
