OsteoArthritis Knee
Conditions
Keywords
Dermabond, Dermabond prineo
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
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?
Interventions
DEVICESkin 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
DEVICEskin 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
Sponsors
Pooriwat Lertsurawat
Kittipon Naratrikun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Observer Scar Assessment Score (POSAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Observer Scar Assessment Score (POSAS) | 3 months | 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. |
| Vancouver Scar Scale | 6 weeks | 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. |
| Wound Leakage | 2 weeks | 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). |
Countries
Thailand
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.43 years STANDARD_DEVIATION 5.97 |
| Alcohol | 2 participants |
| BMI | 28.23 Kg/m2 STANDARD_DEVIATION 4.2 |
| Diabetic mellitus | 6 participants |
| Dyslipidemia | 55 participants |
| Hypertension | 66 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 80 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 39 Participants |
| Smoking | 0 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 38 |
| other Total, other adverse events | 1 / 40 | 4 / 38 |
| serious Total, serious adverse events | 0 / 40 | 0 / 38 |
Outcome results
None listed