Comparison of Skinlink With Suture for ED Patients (Skinlink)
May 17, 2016 updated by: Kim Hyeongtae, Hallym University Kangnam Sacred Heart Hospital
Comparison of Skinlink With Suture for ED Patients: a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, ASI|KR|KS013|SEOUL
- KangNam Sacred Heart Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Skinlink
applying Skinlink on simple laceration (length < 5cm)
|
suture using Skinlink
|
|
OTHER: Nylon
applying conventional suture using nylon on simple laceration (length < 5cm)
|
conventional suture using nylon
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time required to complete suture
Time Frame: 1year
|
1year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Dehiscence
Time Frame: 1year
|
1year
|
|
Infection rate
Time Frame: 1year
|
1year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (ACTUAL)
March 1, 2016
Study Completion (ACTUAL)
April 1, 2016
Study Registration Dates
First Submitted
January 4, 2015
First Submitted That Met QC Criteria
January 5, 2015
First Posted (ESTIMATE)
January 7, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
May 18, 2016
Last Update Submitted That Met QC Criteria
May 17, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Skinlink_SHH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.