Evaluation of Skin Affix in the Emergency Room
Phase 4
Completed
- Conditions
- Wounds
- Interventions
- Procedure: Skin Affix
- Registration Number
- NCT02223689
- Lead Sponsor
- Medline Industries
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Skin Affix Skin Affix Surgical adhesive
- Primary Outcome Measures
Name Time Method Wound Closure at Discharge 14 days Wounds remained closed following application of Skin Affix
- Secondary Outcome Measures
Name Time Method Change in Pain Following Application 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.
Trial Locations
- Locations (1)
MetroHealth System
🇺🇸Cleveland, Ohio, United States