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

January 12, 2012
March 24, 2014
December 2011
August 2014   (final data collection date for primary outcome measure)
Wound closure [ Time Frame: 2-14 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01514396 on ClinicalTrials.gov Archive Site
Number of subjects with adverse events related to wound closure [ Time Frame: 2-14 days ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Wounds
Device: Surgiseal
surgical glue
Other Name: Surgiseal
Experimental: Surgical Glue
Surgiseal
Intervention: Device: Surgiseal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
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
Both
5 Years to 18 Years
Yes
United States
 
NCT01514396
R11-018
No
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