Comparison of Postoperative Wound Between Dermabond Prineo(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) and Subcuticular Suture in Simultaneous Total Knee Arthroplasty

Not Applicable

• Conditions: Osteoarthritis, Knee Cutaneous Suture, Dermabond, Subcuticular Suture
• Interventions: Procedure: DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) vs subcuticular nylon suture

• Registration Number: NCT04506580
• Lead Sponsor: The Catholic University of Korea

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-06
• Study First Submitted: 2020-02-01
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-30
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-06
• Last Update Submitted: 2020-08-06
• Study First Posted: 2020-08-10
• Last Update Posted: 2020-08-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dermabond group	DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) vs subcuticular nylon suture	close capsule using 1-0 vicryl suture material close subq layer using 1-0 and 2-0 bicryl suture material and close skin layer using DERMABOND™ PRINEO™

Primary Outcome Measures

Name	Time	Method
wound Hypertrophy scale at postoperative 6 month	at postoperative 6 months	Vancouver scar scale, patient and observer report scar assessment scale

Secondary Outcome Measures

Name	Time	Method
Stitch out time	postoperative 2 weeks
wound complication	postoperative 6 month
Skin closure time	operation day	Skin closure time for each group
Stitch out visual visual analogue scale(VAS)	postoperative 2 weeks	VAS range from 1 to 10 ( 1means minimal pain 10 means maximal pain)

Trial Locations

Locations (1)

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of