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NCT02333877 Clinical Trial

Comparison of Skinlink With Suture for ED Patients

Wounds and Injuries Clinical Trial

— Skinlink  

Official title:
Comparison of Skinlink With Suture for ED Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02333877
Other study ID # Skinlink_SHH
Secondary ID
Status Completed
Phase N/A
First received January 4, 2015
Last updated May 17, 2016
Start date January 2015
Est. completion date April 2016

Study information
Verified date May 2016
Source Hallym University Kangnam Sacred Heart Hospital
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 49
Est. completion date April 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Skinlink
suture using Skinlink
• Nylon
conventional suture using nylon

Locations
Country Name City State
Korea, Republic of Kangnam Sacred Heart Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time required to complete suture 1year Yes
Secondary Dehiscence 1year Yes
Secondary Infection rate 1year Yes
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