Status:
COMPLETED
Skin Incision Adhesive in Pediatrics
Lead Sponsor:
Medline Industries
Conditions:
Wounds
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief 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 sk...
Detailed Description
Subjects had SurgiSeal™ applied to their topical skin incisions in the ED. Subjects' wounds were evaluated for bleeding and closure of the incision/wound before patient discharge and 48 hours after th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01514396
Start Date
February 1 2013
End Date
August 1 2014
Last Update
December 4 2018
Active Locations (1)
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1
Akron Children's Hospital Emergency Department
Akron, Ohio, United States, 44308