Skin Incision Adhesive in Pediatrics

Wounds Clinical Trial

Official title:

Evaluation of Surgiseal as a Topical Emergency Department Skin Incision Adhesive in Pediatrics A Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514396
• Other study ID #: R11-018
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: August 2014

Study information

• Verified date: August 2017
• Source: Medline Industries
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Subjects had SurgiSeal™ applied to their topical skin incisions in the ED. Subjects' wounds were evaluated for bleeding and closure of the incision/wound before patient discharge and 48 hours after the procedure. Further follow up wound closure evaluations were conducted via telephone interview at 5-10 days and 14 days after the ED visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Wounds

Intervention

Device:
• Surgiseal
surgical glue

Locations

Country	Name	City	State
United States	Akron Children's Hospital Emergency Department	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Medline Industries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Wound Closure	wound closure measured baseline to 14 days	baseline to 14 days
Secondary	Adverse Events Related to Wound Closure	Adverse events reported	14 days