Skin Incision Adhesive in Pediatrics

Medline Industries

Status: Completed

Conditions: Wounds

Treatments: Device: Surgiseal

Study type: Interventional

Funder types: Industry

Identifiers

NCT01514396

R11-018

Details and patient eligibility

About

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).

Full 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 the procedure. Further follow up wound closure evaluations were conducted via telephone interview at 5-10 days and 14 days after the ED visit.

Enrollment: 8 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Surgical Glue

Experimental group

Description:

Surgiseal

Treatment:

Device: Surgiseal