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Status unknownNCT04506580Updated Aug 10, 2020

Comparison of Postoperative Wound Between Dermabond Prineo(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) and Subcuticular Suture in Simultaneous Total Knee Arthroplasty

An interventional study of DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) vs subcuticular nylon suture in Osteoarthritis, Knee Cutaneous Suture, Dermabond, Subcuticular Suture, sponsored by The Catholic University of Korea. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-08-10.

Sponsored by The Catholic University of Korea · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Mar 2019, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
19 Years and older
Sex
All
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Study summary

This study aims to compare the clinical results of postoperative wound between Dermabond PRINEO™(2-octyl Cyanoacrylate adhesive and polyester mesh) and subcuticular suture in simultaneous total knee arthroplasty

There is previous studies over whether or not to use skin adhesive material is superior or inferior to subcuticular suture This study prospectively randomized patients receiving bilateral total knee arthroplasty(TKA). Patients preference and clinical results was investigated in both knee of same patients who received skin adhesive or subcuticular suture in each knee.

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Conditions studied

  • Osteoarthritis, Knee Cutaneous Suture, Dermabond, Subcuticular Suture
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In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's enrollment of 50 is below the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

The Catholic University of Korea is the lead sponsor of 150 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients for total knee arthroplasty
  • having medicare insurance

Exclusion criteria

Exclusion Criteria:

  • Rheumatoid arthritis
  • Other inflammatory arthritis
  • Neuropsychiatric patients
  • Allergy or intolerance to study material
  • Patients with an American Society of Anesthesiologists(ASA) score of IV (angina, congestive heart failure, dementia, cerebrovascular accident)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Dermabond group

    close capsule using 1-0 vicryl suture material close subq layer using 1-0 and 2-0 bicryl suture material and close skin layer using DERMABOND™ PRINEO™

    Procedure: DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) vs subcuticular nylon suture

  • No intervention
    Subcuticular group

    close capsule using 1-0 vicryl suture material close subq layer using 1-0 and 2-0 bicryl suture material and close skin layer using 3-0 Dermalon with subcuticular suture method

Interventions

  • ProcedureDERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) vs subcuticular nylon suture

    DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) and subcuticular nylon suture are applied for each knee

06

What researchers measure

Primary outcomes

  1. wound Hypertrophy scale at postoperative 6 month

    Vancouver scar scale, patient and observer report scar assessment scale

    Time frame: at postoperative 6 months

Secondary outcomes

  1. Skin closure time

    Skin closure time for each group

    Time frame: operation day

  2. wound complication

    Time frame: postoperative 2 weeks

  3. wound complication

    Time frame: postoperative 6 weeks

  4. wound complication

    Time frame: postoperative 3 month

  5. wound complication

    Time frame: postoperative 6 month

  6. Stitch out time

    Time frame: postoperative 2 weeks

  7. Stitch out visual visual analogue scale(VAS)

    VAS range from 1 to 10 ( 1means minimal pain 10 means maximal pain)

    Time frame: postoperative 2 weeks

07

Study locations

1 site
  • Seoul St. Mary's Hospital
    Seoul, 06591, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04506580
Lead sponsor
The Catholic University of Korea
Responsible party
Yong In (Head of Orthopaedic Surgery, The Catholic University of Korea) — Principal investigator
First posted
Aug 10, 2020
Start date
Mar 6, 2019
Primary completion
Jul 1, 2020
Completion
Jul 30, 2020 (estimated)
Last update
Aug 10, 2020

Study contacts

Yong In, MD, PhD
study chair · the Catholic Univerisity of Korea Seoul St Mary's hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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