A Comparison of 2-octyl Cyanoacrylate Skin Adhesive and Polyester Mesh for Wound Closure in Total Knee Arthroplasty, A Randomized Controlled Study
Phase: NA
Conditions: OsteoArthritis Knee
Sponsor: Pooriwat Lertsurawat

CLINICAL STUDY PROTOCOL  
Version: 1.0  
Document Date: October 11, 2023 
NCT06232018  
Title:  
A Comparison of 2-Octyl Cyanoacrylate Skin Adhesive and Polyester Mesh for Wound Closure in Total 
Knee Arthroplasty: A Randomized Controlled Study  
Sponsor:  
Hatyai Hospital, Songkhla, Thailand  
Principal Investigator:  
Pooriwat Lertsurawat, MD  
Email: Pooriwat999@gmail.com  
Phone: +66-876329824  
IRB Approval:  
HYH EC 059-66-01  
1. Background and Rationale  
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? 
2. Objectives  
Primary Objective:  
To compare POSAS scores between skin adhesive alone and skin adhesive with polyester mesh at 6 
weeks.  
Secondary Objectives:  
To compare Vancouver Scar Scale scores, wound leakage area (mm2), wound complications, and 
allergic contact dermatitis.  
3. Study Design  
Prospective, single-center, randomized controlled parallel-group study with 80 participants randomized 
1:1.  
4. Eligibility Criteria  
Inclusion:  
- Age 50–80 years  
- Undergoing primary unilateral TKA  
Exclusion:  
- Prior knee surgery  
- Keloid scar history  
- Psoriasis at operative site  
- Contact dermatitis to adhesive  
- Cognitive impairment  
5. Randomization and Blinding  
Block randomization using block sizes 4 and 6. Allocation concealed with opaque envelopes. Outcome 
assessor blinded.  
 

6. Interventions  
:Every patient received TKA using the same surgical methods and instruments. 
Group 1: 2-octyl cyanoacrylate skin adhesive  
Group 2: 2-octyl cyanoacrylate skin adhesive + polyester mesh  
7. Outcome Measures  
Primary:  
POSAS total score at 6 weeks.  
Secondary:  
POSAS score at 3 months  
Vancouver Scar Scale (VSS) at 6 weeks.  
Wound leakage area measured using 1 mm2 grid.  
Wound complications: dehiscence, superficial infection, allergic contact dermatitis.  
8. Study Procedures and Follow-Up  
- Every patient received TKA using the same surgical methods and instruments and received 
standard postoperative protocol.  
- Following subcuticular suturing, patients were randomized into two treatment arms 
- All wounds in both groups were then covered with a 20 × 10 cm Waterproof Wound Dressing 
- Follow up at 2 weeks post-operative to evaluate wound drainage by placing the waterproof 
dressing on the table grid, then use a millimeter grid to count the number of grid squares stained 
with blood. (Wound leakage measurement).  
- Scar evaluation at 6 weeks (POSAS, VSS).  
9. Statistical Analysis Plan  
Continuous variables assessed for normality.  
- Mann–Whitney U test for nonparametric outcomes.  
- Independent t-test for parametric variables.  
Categorical outcomes: chi-square or Fisher’s exact test.  

Significance level: p < 0.05.  
10. Ethics  
This protocol was approved by the institutional ethics committee (Protocol no. HYH EC 059-66-
01) and was conducted in accordance with the Declaration of Helsinki 
11. Data Handling and Confidentiality  
Participant data will be de-identified and securely stored. Only the research team will have 
access, and confidentiality will be strictly maintained. 
12. Funding  
Supported by Hatyai Hospital Research Fund. No commercial funding.  
End of Protocol.