OsteoArthritis KneeNCT06232018
A Comparison of 2-octyl Cyanoacrylate Skin Adhesive and Polyester Mesh for Wound Closure in Total Knee Arthroplasty, A Randomized Controlled Study
A study testing Skin adhesive (Dermabond) and skin adhesive + polyester mesh (Dermabond prineo) in people with OsteoArthritis Knee, run by Pooriwat Lertsurawat at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- OsteoArthritis Knee
- What is being tested?
- Skin adhesive (Dermabond) and skin adhesive + polyester mesh (Dermabond prineo)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 28 Sep 2023to 14 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- OA knee need for Total knee arthroplasty
- Age 50-80 years old
Who cannot join
- Previous surgery of knee
- History of Keloid, Scar, Psoriasis at the knee
- History of contact dermatitis with skin adhesive
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this 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
Read the 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?
- Conditions
- OsteoArthritis Knee
- Being tested
- Skin adhesive (Dermabond), skin adhesive + polyester mesh (Dermabond prineo)
- Keywords
- Dermabond, Dermabond prineo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Skin adhesive | Experimental | 2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ) Receives: Device: Skin adhesive (Dermabond) |
| skin adhesive Plus polyester mesh | Active comparator | 2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ) Receives: Device: skin adhesive + polyester mesh (Dermabond prineo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (4)
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.
Measured: 3 months
Vancouver Scar Scale
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.
Measured: 6 weeks
Wound Leakage
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).
Measured: 2 weeks
Vancouver Scar Scale
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start28 Sep 2023
- Primary completion14 Jun 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for OsteoArthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pooriwat Lertsurawat
- Sponsor type
- University, hospital or other
- Collaborators
- Kittipon Naratrikun
- Responsible party
- Sponsor-investigator, Pooriwat Lertsurawat, HatYai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232018
- Sponsor's protocol ID
- HYH EC 059-66-01
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2024
- Last updated
- 21 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 32922017Sundaram 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.
PubMed 31691153Choi 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.
PubMed 34024693Khan 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.
PubMed 16434531El-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.
PubMed 23114193Gromov 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.
PubMed 30811354Kim 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.
PubMed 28487090
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of 2-octyl Cyanoacrylate Skin Adhesive and Polyester Mesh for Wound Closure in Total Knee Arthroplasty, A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06232018
- Acronym / sponsor ID
- HYH EC 059-66-01
- Conditions
- OsteoArthritis Knee
- Keywords
- Dermabond, Dermabond prineo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pooriwat LertsurawatUniversity, hospital or other
- Collaborators
- Kittipon Naratrikun
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Posted 21 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin adhesive | Experimental | Device: Skin adhesive (Dermabond)2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ) |
| skin adhesive Plus polyester mesh | Active comparator | Device: skin adhesive + polyester mesh (Dermabond prineo)2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- OA knee need for Total knee arthroplasty
- Age 50-80 years old
Key exclusion criteria (4 listed)
- Previous surgery of knee
- History of Keloid, Scar, Psoriasis at the knee
- History of contact dermatitis with skin adhesive
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Skin adhesive |
| 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 | Device | skin adhesive Plus polyester mesh |
Primary outcome
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.
4 secondary outcomes
Patient Observer Scar Assessment Score (POSAS)
Time frame: 3 months
Vancouver Scar Scale
Time frame: 6 weeks
Wound Leakage
Time frame: 2 weeks
Vancouver Scar Scale
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32922017Kong 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.
- Background: PubMed 31691153Sundaram 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.
- Background: PubMed 34024693Choi 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.
- Background: PubMed 16434531Khan 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.
- Background: PubMed 23114193El-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.
- Background: PubMed 30811354Gromov 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.
- Background: PubMed 28487090Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin adhesive (Dermabond) and skin adhesive + polyester mesh (Dermabond prineo) in people with OsteoArthritis Knee, run by Pooriwat Lertsurawat at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Observer Scar Assessment Score (POSAS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06232018, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.