NCT01514396

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
1 year until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

December 4, 2018

Completed
Last Updated

December 4, 2018

Status Verified

August 1, 2017

Enrollment Period

1.5 years

First QC Date

January 12, 2012

Results QC Date

August 29, 2017

Last Update Submit

November 5, 2018

Conditions

Wounds

Keywords

PediatricWounds

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Wound Closure

    wound closure measured baseline to 14 days

    baseline to 14 days

Secondary Outcomes (1)

  • Adverse Events Related to Wound Closure

    14 days

Study Arms (1)

Surgical Glue

EXPERIMENTAL

Surgiseal

Device: Surgiseal

Interventions

SurgisealDEVICE

surgical glue

Surgical Glue

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akron Children's Hospital Emergency Department

Akron, Ohio, 44308, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

Title
Ed Drower
Organization
Medline Industries, Inc.
edrower@medline.com
847-643-3874

Study Officials

  • Ed Drower, MS

    Medline Industries

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2012

First Posted

January 23, 2012

Study Start

February 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 4, 2018

Results First Posted

December 4, 2018

Record last verified: 2017-08

Locations

US(1)