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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06591
    • Seoul st. mary's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dermabond group; 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™	Procedure: DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) vs subcuticular nylon suture; DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) and subcuticular nylon suture are applied for each knee
No Intervention: Subcuticular group; 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 3-0 Dermalon with subcuticular suture method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound Hypertrophy scale at postoperative 6 month	Vancouver scar scale, patient and observer report scar assessment scale	at postoperative 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin closure time	Skin closure time for each group	operation day
wound complication		postoperative 2 weeks
wound complication		postoperative 6 weeks
wound complication		postoperative 3 month
wound complication		postoperative 6 month
Stitch out time		postoperative 2 weeks
Stitch out visual visual analogue scale(VAS)	VAS range from 1 to 10 ( 1means minimal pain 10 means maximal pain)	postoperative 2 weeks

Collaborators and Investigators

• Sponsor: The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Actual): July 1, 2020
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: February 1, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Dermabond vs. Subcuticular

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No