Back to resultsEvaluation of Skin Affix in the Emergency Room
Primary Purpose
Wounds
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Skin Affix
Sponsored by
About this trial
This is an interventional treatment trial for Wounds focused on measuring SkinAffix
Eligibility Criteria
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
Sites / Locations
- MetroHealth System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Skin Affix
Arm Description
Surgical adhesive
Outcomes
Primary Outcome Measures
Wound Closure at Discharge
Wounds remained closed following application of Skin Affix
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02223689
Brief Title
Evaluation of Skin Affix in the Emergency Room
Official Title
Evaluation of SkinAffix as a Topical Emergency Room Department Skin Incision Adhesive
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medline Industries
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
Keywords
SkinAffix
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Skin Affix
Arm Type
Experimental
Arm Description
Surgical adhesive
Intervention Type
Procedure
Intervention Name(s)
Skin Affix
Primary Outcome Measure Information:
Title
Wound Closure at Discharge
Description
Wounds remained closed following application of Skin Affix
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Change in Pain Following Application
Description
Any 1 point decrease, increase, or no change in pain was measured on a scale--0 =no pain = 5 most pain.
Time Frame
15 minutes Post Application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Schrock, MD
Organizational Affiliation
Metro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MetroHealth System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Skin Affix in the Emergency Room
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