Skip to main content
OpenTrials
Completed

NCT Number: NCT06232018

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pooriwat Lertsurawat

Songkhla, Changwat Songkhla, 90110, Thailand

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin adhesive (Dermabond)

Device
  • Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson & johnson, Somerville, NJ)
  • Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson & johnson, Somerville, NJ)
  • After subticular sutures was done
  • 2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson & johnson, Somerville, NJ) was applied

skin adhesive + polyester mesh (Dermabond prineo)

Device
  • Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson & johnson, Somerville, NJ)
  • Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson & johnson, Somerville, NJ)
  • After subticular sutures was done
  • 2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson & johnson, Somerville, NJ) was applied

Primary outcomes

  1. Patient Observer Scar Assessment Score (POSAS)

    Time frame: 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.

Secondary outcomes

  1. Patient Observer Scar Assessment Score (POSAS)

    Time frame: 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.

  2. Vancouver Scar Scale

    Time frame: 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.

  3. Wound Leakage

    Time frame: 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).

  4. Vancouver Scar Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pooriwat Lertsurawat

Other

Collaborators

  • Kittipon Naratrikun

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.