Skin Incision Adhesive in Pediatrics

November 5, 2018 updated by: Medline Industries

Evaluation of Surgiseal as a Topical Emergency Department Skin Incision Adhesive in Pediatrics A Case Series

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Akron, Ohio, United States, 44308
        • Akron Children's Hospital Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Surgical Glue
Surgiseal
Device: Surgiseal
surgical glue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Wound Closure
Time Frame: baseline to 14 days
wound closure measured baseline to 14 days
baseline to 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events Related to Wound Closure
Time Frame: 14 days
Adverse events reported
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medline Industries

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

January 12, 2012

First Submitted That Met QC Criteria

January 17, 2012

First Posted (ESTIMATE)

January 23, 2012

Study Record Updates

Last Update Posted (ACTUAL)

December 4, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R11-018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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