WoundsPhase 4NCT02223689
Evaluation of Skin Affix in the Emergency Room
A Phase 4 study testing Skin Affix in people with Wounds, run by Medline Industries at 1 site in United States.
Trial summary
Effectiveness of a surgical adhesive on wounds found in Emergency Medicine. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Wounds
- What is being tested?
- Skin Affix
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Sep 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Greater than 5 years of age
- Requires the use of a surgical skin adhesive
- Informed consent signed
Who cannot join
- Sensitivity to topical adhesive products or formaldehyde
- Hx keloid formation, hypotension, diabetes, blood clotting disorders
- Wound infections
- mucosal surfaces or skin exposed to body fluids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of SkinAffix as a Topical Emergency Room Department Skin Incision Adhesive
Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.
Read the detailed description
Subjects were approached for recruitment in the ED when discussing closure options by the physician. Only subjects deemed appropriate for skin glue closures by their treating physician were approached.Subjects were followed at 48 hours post-procedure, 5-10 days, and at 14 days following the ED visit.
- Conditions
- Wounds
- Being tested
- Skin Affix
- Keywords
- SkinAffix
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin AffixProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Skin Affix | Experimental | Surgical adhesive Receives: Procedure: Skin Affix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Closure at Discharge
Wounds remained closed following application of Skin Affix
Measured: 14 days
Secondary outcomes (1)
Change in Pain Following Application
Any 1 point decrease, increase, or no change in pain was measured on a scale--0 =no pain = 5 most pain.
Measured: 15 minutes Post Application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for WoundsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medline Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jon Schrock, MD, Principal investigator, Metro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223689
- Sponsor's protocol ID
- R14-008
- Status last verified
- Feb 2016
- First submitted
- 27 Mar 2014
- Last updated
- 7 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SkinAffix as a Topical Emergency Room Department Skin Incision Adhesive
- ClinicalTrials.gov ID
- NCT02223689
- Acronym / sponsor ID
- R14-008
- Conditions
- Wounds
- Keywords
- SkinAffix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Posted 11 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.
Detailed description
Subjects were approached for recruitment in the ED when discussing closure options by the physician. Only subjects deemed appropriate for skin glue closures by their treating physician were approached.Subjects were followed at 48 hours post-procedure, 5-10 days, and at 14 days following the ED visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin Affix | Experimental | Procedure: Skin AffixSurgical adhesive |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Greater than 5 years of age
- Requires the use of a surgical skin adhesive
- Informed consent signed
Key exclusion criteria (4 listed)
- Sensitivity to topical adhesive products or formaldehyde
- Hx keloid formation, hypotension, diabetes, blood clotting disorders
- Wound infections
- mucosal surfaces or skin exposed to body fluids
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 |
|---|---|---|
| Skin Affix | Procedure or surgery | Skin Affix |
Primary outcome
Wound Closure at Discharge
Time frame: 14 days
Wounds remained closed following application of Skin Affix
1 secondary outcome
Change in Pain Following Application
Time frame: 15 minutes Post Application
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jon Schrock, MD principal investigator
Metro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Skin Affix in people with Wounds, run by Medline Industries at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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 7 Aug 2019. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Wound Closure at Discharge (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2019.