Skin Incision Adhesive in Pediatrics

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Medline Industries
Sponsor:
Information provided by (Responsible Party):
Medline Industries
ClinicalTrials.gov Identifier:
NCT01514396
First received: January 12, 2012
Last updated: March 24, 2014
Last verified: March 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Surgiseal as a Topical Emergency Department Skin Incision Adhesive in Pediatrics A Case Series

Further study details as provided by Medline Industries:

Primary Outcome Measures:
  • Wound closure [ Time Frame: 2-14 days ] [ Designated as safety issue: Yes ]

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

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
Other Name: Surgiseal

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT01514396     History of Changes
Other Study ID Numbers: R11-018
Study First Received: January 12, 2012
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medline Industries:
Pediatric
Wounds

ClinicalTrials.gov processed this record on July 24, 2014