search
Back to results

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

Primary Purpose

Osteoarthritis, Knee Cutaneous Suture, Dermabond, Subcuticular Suture

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) vs subcuticular nylon suture
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee Cutaneous Suture, Dermabond, Subcuticular Suture

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dermabond group

Subcuticular group

Arm Description

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™

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

Outcomes

Primary Outcome Measures

wound Hypertrophy scale at postoperative 6 month
Vancouver scar scale, patient and observer report scar assessment scale

Secondary Outcome Measures

Skin closure time
Skin closure time for each group
wound complication
wound complication
wound complication
wound complication
Stitch out time
Stitch out visual visual analogue scale(VAS)
VAS range from 1 to 10 ( 1means minimal pain 10 means maximal pain)

Full Information

First Posted
February 1, 2020
Last Updated
August 6, 2020
Sponsor
The Catholic University of Korea
search

1. Study Identification

Unique Protocol Identification Number
NCT04506580
Brief Title
Comparison of Postoperative Wound Between Dermabond Prineo(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) and Subcuticular Suture in Simultaneous Total Knee Arthroplasty
Official Title
Comparison of Postoperative Wound Between Dermabond PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) and Subcuticular Suture in Simultaneous Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee Cutaneous Suture, Dermabond, Subcuticular Suture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dermabond group
Arm Type
Experimental
Arm Description
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™
Arm Title
Subcuticular group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) vs subcuticular nylon suture
Intervention Description
DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) and subcuticular nylon suture are applied for each knee
Primary Outcome Measure Information:
Title
wound Hypertrophy scale at postoperative 6 month
Description
Vancouver scar scale, patient and observer report scar assessment scale
Time Frame
at postoperative 6 months
Secondary Outcome Measure Information:
Title
Skin closure time
Description
Skin closure time for each group
Time Frame
operation day
Title
wound complication
Time Frame
postoperative 2 weeks
Title
wound complication
Time Frame
postoperative 6 weeks
Title
wound complication
Time Frame
postoperative 3 month
Title
wound complication
Time Frame
postoperative 6 month
Title
Stitch out time
Time Frame
postoperative 2 weeks
Title
Stitch out visual visual analogue scale(VAS)
Description
VAS range from 1 to 10 ( 1means minimal pain 10 means maximal pain)
Time Frame
postoperative 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong In, MD, PhD
Organizational Affiliation
the Catholic Univerisity of Korea Seoul St Mary's hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs