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NCT06232018

A Comparison of 2-octyl Cyanoacrylate Skin Adhesive and Polyester Mesh for Wound Closure in Total Knee Arthroplasty, A Randomized Controlled Study

Completed NA Results posted Last updated 21 January 2026
What this trial tests

NA trial testing Skin adhesive (Dermabond) in OsteoArthritis Knee in 80 participants. Completed in 14 June 2024.

Timeline
28 September 2023
Primary endpoint
14 June 2024
14 June 2024

Quick facts

Lead sponsorPooriwat Lertsurawat
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment80
Start date28 September 2023
Primary completion14 June 2024
Estimated completion14 June 2024
Sites1 location across Thailand

Drugs / interventions tested

Conditions studied

Sponsor

Pooriwat Lertsurawat

Who can join

Adults 50 to 80, any sex, with OsteoArthritis Knee. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Observer Scar Assessment Score (POSAS) Primary · 6 weeks

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.

GroupValue95% CI
Skin Adhesive2014 – 26
Skin Adhesive Plus Polyester Mesh2114 – 26
Patient Observer Scar Assessment Score (POSAS) Secondary · 3 months

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.

GroupValue95% CI
Skin Adhesive1310 – 19
Skin Adhesive Plus Polyester Mesh1510 – 20
Vancouver Scar Scale Secondary · 6 weeks

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.

GroupValue95% CI
Skin Adhesive55 – 6
Skin Adhesive Plus Polyester Mesh55 – 6
Wound Leakage Secondary · 2 weeks

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).

GroupValue95% CI
Skin Adhesive239.8 – 57.5
Skin Adhesive Plus Polyester Mesh7942.8 – 108.8
Vancouver Scar Scale Secondary · 3 months

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.

GroupValue95% CI
Skin Adhesive55 – 6
Skin Adhesive Plus Polyester Mesh55 – 6

Adverse events — posted to ClinicalTrials.gov

Time frame: From 2 weeks to 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Skin Adhesive
Serious: 0/40 (0%)
Deaths: 0/40
Skin Adhesive Plus Polyester Mesh
Serious: 0/38 (0%)
Deaths: 0/38
Other adverse events (1 terms — click to expand)

ReactionSystemSkin AdhesiveSkin Adhesive Plus Polyest…
Allergic contact dermatitisSurgical and medical procedures

Data from ClinicalTrials.gov NCT06232018 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing