Wounds and InjuriesSkinlinkNCT02333877
Comparison of Skinlink With Suture for ED Patients
A study testing Skinlink and Nylon in people with Wounds and Injuries and Lacerations, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds and Injuries, Lacerations
- What is being tested?
- Skinlink and Nylon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Wounds and Injuries, Lacerations
- Being tested
- Skinlink, Nylon
- Medical subject headings
- Wounds and Injuries, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SkinlinkOther
suture using Skinlink
NylonOther
conventional suture using nylon
| Study group | Role | What they receive |
|---|---|---|
| Skinlink | Experimental | applying Skinlink on simple laceration (length < 5cm) Receives: Other: Skinlink |
| Nylon | Other | applying conventional suture using nylon on simple laceration (length < 5cm) Receives: Other: Nylon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required to complete suture
Measured: 1year
Secondary outcomes (2)
Dehiscence
Measured: 1year
Infection rate
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Hyeongtae, Hallym University Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333877
- Sponsor's protocol ID
- Skinlink_SHH
- Acronym
- Skinlink
- Status last verified
- May 2016
- First submitted
- 4 Jan 2015
- Last updated
- 18 May 2016
- Results posted
- No
Publications
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.
PubMed 29923977
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Skinlink With Suture for ED Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02333877
- Acronym / sponsor ID
- Skinlink / Skinlink_SHH
- Conditions
- Wounds and Injuries, Lacerations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skinlink | Experimental | Other: Skinlinkapplying Skinlink on simple laceration (length < 5cm) |
| Nylon | Other | Other: Nylonapplying conventional suture using nylon on simple laceration (length < 5cm) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skinlinksuture using Skinlink | Other | Skinlink |
| Nylonconventional suture using nylon | Other | Nylon |
Primary outcome
Time required to complete suture
Time frame: 1year
2 secondary outcomes
Dehiscence
Time frame: 1year
Infection rate
Time frame: 1year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Derived from this study: PubMed 29923977Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skinlink and Nylon in people with Wounds and Injuries and Lacerations, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required to complete suture (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02333877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.