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OpenTrials
Completed

NCT Number: NCT01514396

Skin Incision Adhesive in Pediatrics

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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Key information

Conditions

Wounds Wounds and Injuries

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akron Children's Hospital Emergency Department

Akron, Ohio, 44308, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgiseal

Device

surgical glue

Primary outcomes

  1. Number of Participants With Wound Closure

    Time frame: baseline to 14 days

    wound closure measured baseline to 14 days

Secondary outcomes

  1. Adverse Events Related to Wound Closure

    Time frame: 14 days

    Adverse events reported

Sponsors and collaborators

Lead sponsor

Medline Industries

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 23, 2012
Registry last updated
Dec 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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