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Skin Incision Adhesive in Pediatrics

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by Medline Industries.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01514396
First Posted: January 23, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medline Industries
  Purpose
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 Intervention Phase
Wounds Device: Surgiseal Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medline Industries:

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

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

Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgical Glue
Surgiseal
Device: Surgiseal
surgical glue

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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


Locations
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
  More Information

Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT01514396     History of Changes
Other Study ID Numbers: R11-018
First Submitted: January 12, 2012
First Posted: January 23, 2012
Last Update Posted: October 12, 2017
Last Verified: March 2014

Keywords provided by Medline Industries:
Pediatric
Wounds