Phase 4
N=35
Evaluation of Skin Affix in the Emergency Room
Wounds
Bottom Line
View on ClinicalTrials.gov: NCT02223689 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Wound Closure at Discharge — 100 percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Skin Affix (Procedure)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Medline Industries
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Closure at Discharge |
100 | — |
| SECONDARY Change in Pain Following Application |
8.6; 22.9; 57.1 | — |
Summary
Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.
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
Data sourced from ClinicalTrials.gov (NCT02223689). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.