Back to resultsComparison of Skinlink With Suture for ED Patients (Skinlink)
Primary Purpose
Wounds and Injuries, Lacerations
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Skinlink
Nylon
Sponsored by
About this trial
This is an interventional treatment trial for Wounds and Injuries
Eligibility Criteria
The inclusion criteria were age 18-75 years,presence of a partial thickness laceration, generally good health without systemic abnormalities,agreement to return for a 14-day follow-up, and written informed consent. The exclusion criteria were previous diagnosis of diabetes mellitus, peripheral vascular disease, or bleeding disorders; history of keloid formation or scar hypertrophy; and allergy to cyanoacrylate compounds or formaldehyde
Sites / Locations
- Kangnam Sacred Heart Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Skinlink
Nylon
Arm Description
applying Skinlink on simple laceration (length < 5cm)
applying conventional suture using nylon on simple laceration (length < 5cm)
Outcomes
Primary Outcome Measures
Time required to complete suture
Secondary Outcome Measures
Dehiscence
Infection rate
Full Information
NCT ID
NCT02333877
First Posted
January 4, 2015
Last Updated
May 17, 2016
Sponsor
Hallym University Kangnam Sacred Heart Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02333877
Brief Title
Comparison of Skinlink With Suture for ED Patients
Acronym
Skinlink
Official Title
Comparison of Skinlink With Suture for ED Patients: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hallym University Kangnam Sacred Heart Hospital
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether suture using the Device of "Leukosan Skinlink" is more faster and safer than that of "nylon" in the treatment of simple wound for ED patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries, Lacerations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Skinlink
Arm Type
Experimental
Arm Description
applying Skinlink on simple laceration (length < 5cm)
Arm Title
Nylon
Arm Type
Other
Arm Description
applying conventional suture using nylon on simple laceration (length < 5cm)
Intervention Type
Other
Intervention Name(s)
Skinlink
Intervention Description
suture using Skinlink
Intervention Type
Other
Intervention Name(s)
Nylon
Intervention Description
conventional suture using nylon
Primary Outcome Measure Information:
Title
Time required to complete suture
Time Frame
1year
Secondary Outcome Measure Information:
Title
Dehiscence
Time Frame
1year
Title
Infection rate
Time Frame
1year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
The inclusion criteria were age 18-75 years,presence of a partial thickness laceration, generally good health without systemic abnormalities,agreement to return for a 14-day follow-up, and written informed consent. The exclusion criteria were previous diagnosis of diabetes mellitus, peripheral vascular disease, or bleeding disorders; history of keloid formation or scar hypertrophy; and allergy to cyanoacrylate compounds or formaldehyde
Facility Information:
Facility Name
Kangnam Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
ASI|KR|KS013|SEOUL
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
29923977
Citation
Kim H, Kim W, Kang GH, Jang YS, Choi HY, Kim JG, Kim IY, Kim M. Comparison of Leukosan SkinLink with surgical suture for traumatic laceration repair: A randomized controlled trial. Medicine (Baltimore). 2018 Jun;97(25):e10918. doi: 10.1097/MD.0000000000010918.
Results Reference
derived
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Comparison of Skinlink With Suture for ED Patients
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