Skin Incision Adhesive in Pediatrics

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. 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

January 12, 2012
January 23, 2012
March 26, 2014
December 2011
August 2014   (Final data collection date for primary outcome measure)
Wound closure [ Time Frame: 2-14 days ]
Same as current
Complete list of historical versions of study NCT01514396 on Archive Site
Number of subjects with adverse events related to wound closure [ Time Frame: 2-14 days ]
Same as current
Not Provided
Not Provided
Skin Incision Adhesive in Pediatrics
Evaluation of Surgiseal as a Topical Emergency Department Skin Incision Adhesive in Pediatrics A Case Series
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).
Not Provided
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Device: Surgiseal
surgical glue
Experimental: Surgical Glue
Intervention: Device: Surgiseal
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
September 2014
August 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Medline Industries
Medline Industries
Not Provided
Not Provided
Medline Industries
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP