Comparison of Postoperative Wound Between Dermabond Prineo(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) and Subcuticular Suture in Simultaneous Total Knee Arthroplasty

Study Overview
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Brief Summary
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This study aims to compare the clinical results of postoperative wound between Dermabond PRINEO™(2-octyl Cyanoacrylate adhesive and polyester mesh) and subcuticular suture in simultaneous total knee arthroplasty There is previous studies over whether or not to use skin adhesive material is superior or inferior to subcuticular suture This study prospectively randomized patients receiving bilateral total knee arthroplasty(TKA). Patients preference and clinical results was investigated in both knee of same patients who received skin adhesive or subcuticular suture in each knee.

Official Title
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Comparison of Postoperative Wound Between Dermabond PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) and Subcuticular Suture in Simultaneous Total Knee Arthroplasty

Conditions
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Osteoarthritis, Knee Cutaneous Suture, Dermabond, Subcuticular Suture

Intervention / Treatment
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* Procedure: DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) vs subcuticular nylon suture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients for total knee arthroplasty having medicare insurance Exclusion Criteria: Rheumatoid arthritis Other inflammatory arthritis Neuropsychiatric patients Allergy or intolerance to study material Patients with an American Society of Anesthesiologists(ASA) score of IV (angina, congestive heart failure, dementia, cerebrovascular accident)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermabond group<br>close capsule using 1-0 vicryl suture material close subq layer using 1-0 and 2-0 bicryl suture material and close skin layer using DERMABOND™ PRINEO™ | Procedure: DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) vs subcuticular nylon suture<br>* DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) and subcuticular nylon suture are applied for each knee<br>|
| No Intervention: Subcuticular group<br>close capsule using 1-0 vicryl suture material close subq layer using 1-0 and 2-0 bicryl suture material and close skin layer using 3-0 Dermalon with subcuticular suture method | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound Hypertrophy scale at postoperative 6 month | Vancouver scar scale, patient and observer report scar assessment scale | at postoperative 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin closure time | Skin closure time for each group | operation day | 
| wound complication |  | postoperative 2 weeks | 
| wound complication |  | postoperative 6 weeks | 
| wound complication |  | postoperative 3 month | 
| wound complication |  | postoperative 6 month | 
| Stitch out time |  | postoperative 2 weeks | 
| Stitch out visual visual analogue scale(VAS) | VAS range from 1 to 10 ( 1means minimal pain 10 means maximal pain) | postoperative 2 weeks |