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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
Information provided by (Responsible Party):
Medline Industries Identifier:
First received: January 12, 2012
Last updated: March 24, 2014
Last verified: March 2014
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
Device: Surgiseal
surgical glue


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
  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 identifier: 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
  More Information

Responsible Party: Medline Industries Identifier: NCT01514396     History of Changes
Other Study ID Numbers: R11-018
Study First Received: January 12, 2012
Last Updated: March 24, 2014

Keywords provided by Medline Industries:
Wounds processed this record on September 20, 2017