Skin Incision Adhesive in Pediatrics
This study is currently recruiting participants.
Verified January 2012 by Medline Industries
Sponsor:
Medline Industries
Information provided by (Responsible Party):
Medline Industries
ClinicalTrials.gov Identifier:
NCT01514396
First received: January 12, 2012
Last updated: January 17, 2012
Last verified: January 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate the effectiveness of on-label use of Octylseal™ 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: cyanoacrylate (Octylseal) |
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 Octylseal 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: | March 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Surgical Glue
Surgical glue.
|
Device: cyanoacrylate (Octylseal)
surgical glue
Other Name: cyanoacrylate
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514396
Locations
| United States, New York | |
| JCMC | Recruiting |
| Nersey City, New York, United States, 07302 | |
| Contact: Dr. Michael Bessette, MD 201-915-2928 bessettem@emand.com | |
| Principal Investigator: Michael Bessette, MD | |
| Wyckoff Hospital | Recruiting |
| New York, New York, United States | |
| Contact: Akella Chendresekhar, MD 718-963-7602 achendra@aol.com | |
| Principal Investigator: Akella Chendresekhar, MD | |
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: | January 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Medline Industries:
|
Pediatric Wounds |
ClinicalTrials.gov processed this record on June 17, 2013