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

January 3, 2026 updated by: Pooriwat Lertsurawat

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Changwat Songkhla
      • Songkhla, Changwat Songkhla, Thailand, 90110
        • Pooriwat Lertsurawat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skin adhesive
2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson & johnson, Somerville, NJ)
Device: Skin adhesive (Dermabond)
  • 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
Active Comparator: skin adhesive Plus polyester mesh
2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson & johnson, Somerville, NJ)
Device: skin adhesive + polyester mesh (Dermabond prineo)
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
6 weeks
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).
2 weeks
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pooriwat Lertsurawat

Collaborators

Kittipon Naratrikun

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2023

Primary Completion (Actual)

June 14, 2024

Study Completion (Actual)

June 14, 2024

Study Registration Dates

First Submitted

January 20, 2024

First Submitted That Met QC Criteria

January 20, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYH EC 059-66-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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