Skin Incision Adhesive in Pediatrics

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-08-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Wounds

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical Glue

Surgiseal

Group Type EXPERIMENTAL

Surgiseal

Intervention Type DEVICE

surgical glue

Interventions

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Surgiseal

surgical glue

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes