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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06232018
Other study ID # HYH EC 059-66-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 28, 2023
Est. completion date December 1, 2024

Study information

Verified date June 2024
Source HatYai Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 arthroplasty different in Patient satisfaction evaluated by POSAS score


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?


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date December 1, 2024
Est. primary completion date September 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Thailand Pooriwat Lertsurawat Songkhla

Sponsors (2)

Lead Sponsor Collaborator
Pooriwat Lertsurawat Kittipon Naratrikun

Country where clinical trial is conducted

Thailand, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Eur J Orthop Surg Traumatol. 2020 Mar 31;: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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, 3 months
Secondary 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, height, pliability, and pigmentation
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 10 and corresponds to the worst skin.
6weeks, 3 months
Secondary Wound complication Evaluated wound complication ( Wound dehiscence Superficial wound infection Allergic contact dermatitis)
Outcome Measure reported as number of patients had developed wound complication within 3 months follow up and calculated proportion of wound complication in percentage
Within 3 months
Secondary Wound drainage Evaluated by Count table of blood strike on Water proof dressing
Outcome Measure by Count number of blood strike on water proof dressing by put the water proof dressing on the table grid square millimeter and count blood strike Reported as Number of blood strike as square millimeter
2 weeks
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