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

Not Applicable

Active, not recruiting

• Conditions: OsteoArthritis Knee
• Interventions: Device: skin adhesive + polyester mesh (Dermabond prineo); Device: Skin adhesive (Dermabond)

• Registration Number: NCT06232018
• Lead Sponsor: Pooriwat Lertsurawat

Brief Summary

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

Detailed Description

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?

Study Timeline

• Study Start: 2023-09-28
• Study First Submitted: 2024-01-20
• Study First Submitted QC: 2024-01-20
• Study First Posted: 2024-01-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-09-28
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
skin adhesive Plus polyester mesh	skin adhesive + polyester mesh (Dermabond prineo)	2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ)
Skin adhesive	Skin adhesive (Dermabond)	2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ)

Primary Outcome Measures

Name	Time	Method
Patient observer scar assessment score (POSAS)	6 weeks, 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.

Secondary Outcome Measures

Name	Time	Method
Vancouver scar scale	6weeks, 3 months	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.
Wound complication	Within 3 months	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
Wound drainage	2 weeks	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

Trial Locations

Locations (1)

Pooriwat Lertsurawat; 🇹🇭 Songkhla, Thailand