Osteoarthritis, Knee Cutaneous Suture, Dermabond, Subcuticular Suture Clinical Trial
Official title:
Comparison of Postoperative Wound Between Dermabond PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) and Subcuticular Suture in Simultaneous Total Knee Arthroplasty
| Verified date | August 2020 |
| Source | The Catholic University of Korea |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study aims to compare the clinical results of postoperative wound between Dermabond
PRINEO™(2-octyl Cyanoacrylate adhesive and polyester mesh) and subcuticular suture in
simultaneous total knee arthroplasty
There is previous studies over whether or not to use skin adhesive material is superior or
inferior to subcuticular suture This study prospectively randomized patients receiving
bilateral total knee arthroplasty(TKA). Patients preference and clinical results was
investigated in both knee of same patients who received skin adhesive or subcuticular suture
in each knee.
| Status | Active, not recruiting |
| Enrollment | 50 |
| Est. completion date | July 30, 2020 |
| Est. primary completion date | July 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility |
Inclusion Criteria: - Patients for total knee arthroplasty - having medicare insurance Exclusion Criteria: - Rheumatoid arthritis - Other inflammatory arthritis - Neuropsychiatric patients - Allergy or intolerance to study material - Patients with an American Society of Anesthesiologists(ASA) score of IV (angina, congestive heart failure, dementia, cerebrovascular accident) |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul St. Mary's Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| The Catholic University of Korea |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | wound Hypertrophy scale at postoperative 6 month | Vancouver scar scale, patient and observer report scar assessment scale | at postoperative 6 months | |
| Secondary | Skin closure time | Skin closure time for each group | operation day | |
| Secondary | wound complication | postoperative 2 weeks | ||
| Secondary | wound complication | postoperative 6 weeks | ||
| Secondary | wound complication | postoperative 3 month | ||
| Secondary | wound complication | postoperative 6 month | ||
| Secondary | Stitch out time | postoperative 2 weeks | ||
| Secondary | Stitch out visual visual analogue scale(VAS) | VAS range from 1 to 10 ( 1means minimal pain 10 means maximal pain) | postoperative 2 weeks |