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

P

Pooriwat Lertsurawat

Status

Active, not recruiting

Conditions

OsteoArthritis Knee

Treatments

Device: Skin adhesive (Dermabond)
Device: skin adhesive + polyester mesh (Dermabond prineo)

Study type

Interventional

Funder types

Other

Identifiers

NCT06232018
HYH EC 059-66-01

Details and patient eligibility

About

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

Full 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?

Enrollment

80 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups

Skin adhesive
Experimental group
Description:
2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ)
Treatment:
Device: Skin adhesive (Dermabond)
skin adhesive Plus polyester mesh
Active Comparator group
Description:
2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ)
Treatment:
Device: skin adhesive + polyester mesh (Dermabond prineo)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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