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Skin Incision Adhesive in Pediatrics

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ClinicalTrials.gov Identifier: NCT01514396
Recruitment Status : Unknown
Verified March 2014 by Medline Industries.
Recruitment status was:  Recruiting
First Posted : January 23, 2012
Last Update Posted : March 26, 2014
Information provided by (Responsible Party):
Medline Industries

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 skin in children presenting in the Emergency Department (ED).

Condition or disease Intervention/treatment Phase
Wounds Device: Surgiseal Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Surgiseal as a Topical Emergency Department Skin Incision Adhesive in Pediatrics A Case Series
Study Start Date : December 2011
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Surgical Glue
Device: Surgiseal
surgical glue

Primary Outcome Measures :
  1. Wound closure [ Time Frame: 2-14 days ]

Secondary Outcome Measures :
  1. Number of subjects with adverse events related to wound closure [ Time Frame: 2-14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514396

United States, New York
JCMC Terminated
Nersey City, New York, United States, 07302
Wyckoff Hospital Terminated
New York, New York, United States
United States, Ohio
Akron Children's Hospital Emergency Department Recruiting
Akron, Ohio, United States, 44308
Contact: Eric Lloyd, RN    330-543-4578      
Principal Investigator: Eric Lloyd, RN         
Sponsors and Collaborators
Medline Industries

Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT01514396     History of Changes
Other Study ID Numbers: R11-018
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

Keywords provided by Medline Industries: