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

NCT06232018 | Completed Results FDA Device

• 1 other identifier: HYH EC 059-66-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

OsteoArthritis Knee

Keywords

Dermabond; Dermabond prineo

Outcome Measures

Primary Outcomes (1)

• Patient Observer Scar Assessment Score (POSAS)

  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 Outcomes (4)

• Patient Observer Scar Assessment Score (POSAS)

  3 months

• Vancouver Scar Scale

  6 weeks

• Wound Leakage

  2 weeks

• Vancouver Scar Scale

  3 months

Study Arms (2)

Skin adhesive

EXPERIMENTAL

2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ)

Device: Skin adhesive (Dermabond)

skin adhesive Plus polyester mesh

ACTIVE COMPARATOR

2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ)

Device: skin adhesive + polyester mesh (Dermabond prineo)

Interventions

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

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

skin adhesive Plus polyester mesh

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OA knee need for Total knee arthroplasty
• Age 50-80 years old

You may not qualify if:

• Previous surgery of knee
• History of Keloid, Scar, Psoriasis at the knee
• History of contact dermatitis with skin adhesive
• Cognitive impairment

Sponsors & Collaborators

• Pooriwat Lertsurawat: lead
• Kittipon Naratrikun: collaborator

Study Sites (1)

Pooriwat Lertsurawat

Songkhla, Changwat Songkhla, 90110, Thailand

Location

Related Publications (7)

• Kong X, Yang M, Guo R, Chen J, Chai W, Wang Y. A Prospective, Randomized and Controlled Study on Tissue Adhesive for Skin Incision in Total Knee Arthroplasty. Ther Clin Risk Manag. 2020 Aug 24;16:795-802. doi: 10.2147/TCRM.S260007. eCollection 2020.

  PMID: 32922017 BACKGROUND

• Sundaram K, Piuzzi NS, Patterson BM, Stearns KL, Krebs VE, Mont MA. Skin closure with 2-octyl cyanoacrylate and polyester mesh after primary total knee arthroplasty offers superior cosmetic outcomes and patient satisfaction compared to staples: a prospective trial. Eur J Orthop Surg Traumatol. 2020 Apr;30(3):447-453. doi: 10.1007/s00590-019-02591-4. Epub 2019 Nov 5.

  PMID: 31691153 BACKGROUND

• Choi KY, Koh IJ, Kim MS, Park DC, Sung YG, In Y. 2-Octyl Cyanoacrylate Topical Adhesive as an Alternative to Subcuticular Suture for Skin Closure After Total Knee Arthroplasty: A Randomized Controlled Trial in the Same Patient. J Arthroplasty. 2021 Sep;36(9):3141-3147. doi: 10.1016/j.arth.2021.04.033. Epub 2021 May 3.

  PMID: 34024693 BACKGROUND

• Khan RJ, Fick D, Yao F, Tang K, Hurworth M, Nivbrant B, Wood D. A comparison of three methods of wound closure following arthroplasty: a prospective, randomised, controlled trial. J Bone Joint Surg Br. 2006 Feb;88(2):238-42. doi: 10.1302/0301-620X.88B2.16923.

  PMID: 16434531 BACKGROUND

• El-Gazzar Y, Smith DC, Kim SJ, Hirsh DM, Blum Y, Cobelli M, Cohen HW. The use of dermabond(R) as an adjunct to wound closure after total knee arthroplasty: examining immediate post-operative wound drainage. J Arthroplasty. 2013 Apr;28(4):553-6. doi: 10.1016/j.arth.2012.07.038. Epub 2012 Oct 29.

  PMID: 23114193 BACKGROUND

• Gromov K, Troelsen A, Raaschou S, Sandhold H, Nielsen CS, Kehlet H, Husted H. Tissue Adhesive for Wound Closure Reduces Immediate Postoperative Wound Dressing Changes After Primary TKA: A Randomized Controlled Study in Simultaneous Bilateral TKA. Clin Orthop Relat Res. 2019 Sep;477(9):2032-2038. doi: 10.1097/CORR.0000000000000637.

  PMID: 30811354 BACKGROUND

• Kim KY, Anoushiravani AA, Long WJ, Vigdorchik JM, Fernandez-Madrid I, Schwarzkopf R. A Meta-Analysis and Systematic Review Evaluating Skin Closure After Total Knee Arthroplasty-What Is the Best Method? J Arthroplasty. 2017 Sep;32(9):2920-2927. doi: 10.1016/j.arth.2017.04.004. Epub 2017 Apr 12.

  PMID: 28487090 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

This study has several limitations. First, it is a single-center design, so it may restrict the generalizability of our findings to other institutions and patient populations Second, all procedures were done by one experienced hip and knee arthroplasty surgeon, who had an individual technique that could have influenced wound closure quality Third, our primary outcome was the Patient and Observer which relies on patient and research assessor and may have some bias

Results Point of Contact

• Title: Pooriwat Lertsurawat
• Organization: Hatyai hospital

Pooriwat999@gmail.com

087-6329824

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Orthopedic of Hatyai Hospital

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: January 30, 2024
• Study Start: September 28, 2023
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2024
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2026-01

Locations

TH (1)