N/A
Completed N=8
Skin Incision Adhesive in Pediatrics
Source: ClinicalTrials.gov NCT01514396 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Number of Participants With Wound Closure — 8 participants
Summary
The purpose of this study is to evaluate the effectiveness of on-label use of Surgiseal™ Tissue Adhesive, a cyanoacrylate-based Surgical Topical Skin Tissue Adhesive in wound closure of the topical skin in children presenting in the Emergency Department (ED).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Wound Closure |
8 | — |
| SECONDARY Adverse Events Related to Wound Closure |
— | — |
Eligibility Criteria
Inclusion Criteria
- Between the ages of 5 and 18 years of age, inclusive
- Candidate for use of a topical surgical skin adhesive
- Informed consent by a parental guardian
Exclusion Criteria
- A wound with evidence of active infection or gangrene or wounds of decubitus etiology
- Mucosal surfaces or across mucocutaneous junctions or skin that might be exposed to body fluids or dense natural hair
- Subjects with known hypersensitivity to cyanoacrylate or formaldehyde
Data sourced from ClinicalTrials.gov (NCT01514396). 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. Informational only — not medical advice.