N/A N=8 Treatment

Skin Incision Adhesive in Pediatrics

Wounds

Bottom Line

View on ClinicalTrials.gov: NCT01514396 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2018

Primary outcome: Primary: Number of Participants With Wound Closure — 8 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Surgiseal (Device)
Age: Pediatric, Adult · 5+ yrs
Sex: All
Sponsor: Medline Industries
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Wound Closure	8	—
SECONDARY Adverse Events Related to Wound Closure	—	—

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).

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

View full record on ClinicalTrials.gov →

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.