NCT02333877

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

January 4, 2015

Last Update Submit

May 17, 2016

Conditions

Wounds and InjuriesLacerations

Outcome Measures

Primary Outcomes (1)

  • Time required to complete suture

    1year

Secondary Outcomes (2)

  • Dehiscence

    1year

  • Infection rate

    1year

Study Arms (2)

Skinlink

EXPERIMENTAL

applying Skinlink on simple laceration (length \< 5cm)

Other: Skinlink

Nylon

OTHER

applying conventional suture using nylon on simple laceration (length \< 5cm)

Other: Nylon

Interventions

SkinlinkOTHER

suture using Skinlink

Skinlink
NylonOTHER

conventional suture using nylon

Nylon

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangnam Sacred Heart Hospital

Seoul, ASI|KR|KS013|SEOUL, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 29923977DERIVED

MeSH Terms

Conditions

Wounds and InjuriesLacerations

Interventions

Nylons

Intervention Hierarchy (Ancestors)

PlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Residency

Study Record Dates

First Submitted

January 4, 2015

First Posted

January 7, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations

KR(1)