- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02223689
Evaluation of Skin Affix in the Emergency Room
July 29, 2019 updated by: Medline Industries
Evaluation of SkinAffix as a Topical Emergency Room Department Skin Incision Adhesive
Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.
Study Overview
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 Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 4
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
-
-
Ohio
-
Cleveland, Ohio, United States, 44109
- MetroHealth System
-
-
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
3 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Greater than 5 years of age
- Requires the use of a surgical skin adhesive
- Informed consent signed
Exclusion Criteria:
- 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
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Skin Affix
Surgical adhesive
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound Closure at Discharge
Time Frame: 14 days
|
Wounds remained closed following application of Skin Affix
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain Following Application
Time Frame: 15 minutes Post Application
|
Any 1 point decrease, increase, or no change in pain was measured on a scale--0 =no pain = 5 most pain.
|
15 minutes Post Application
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jon Schrock, MD, Metro Hospital
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
July 1, 2014
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
March 27, 2014
First Submitted That Met QC Criteria
August 20, 2014
First Posted (Estimate)
August 22, 2014
Study Record Updates
Last Update Posted (Actual)
August 7, 2019
Last Update Submitted That Met QC Criteria
July 29, 2019
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R14-008
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.
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