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A Randomized Clinical Trial Comparing Tissue Adhesive (2-Octylcyanoacrylate) Vs. Absorbable Suture Vs. Non-Absorbable Suture for the Closure of Low Tension Facial and Neck Wounds in Children and Adolescents


N/A
N/A
18 Years
Open (Enrolling)
Both
Cyst of Face, Neck or Shoulder, Pilomatrixoma of Face, Neck or Shoulder

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Trial Information

A Randomized Clinical Trial Comparing Tissue Adhesive (2-Octylcyanoacrylate) Vs. Absorbable Suture Vs. Non-Absorbable Suture for the Closure of Low Tension Facial and Neck Wounds in Children and Adolescents


Inclusion Criteria:



- Age less than or equal to 18

- Pre-operative diagnosis of cyst or pilomatrixoma of neck, face or shoulder

- outpatient scheduled for outpatient or day surgery at Children's Hospital San Diego

Exclusion Criteria:

- known hypersensitivity to cyanoacrylate or formaldehyde

- lesions with any evidence of active infection or gangrene

- lesions on or across mucocutaneous surfaces

- lesions in which skin may be regularly exposed to body fluids

- lesions located in areas of dense natural hair (ie scalp)

- patients with peripheral vascular disease, insulin dependent diabetes mellitis or
blood clotting disorders

- patients with known immunodeficiencies

- inability to return for follow-up

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Bari B Cunningham, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rady Children's Hospital, San Diego

Authority:

United States: Institutional Review Board

Study ID:

Dermabond Study

NCT ID:

NCT00292513

Start Date:

Completion Date:

Related Keywords:

  • Cyst of Face, Neck or Shoulder
  • Pilomatrixoma of Face, Neck or Shoulder
  • Pilomatrixoma

Name

Location

Children's Hospital San Diego San Diego, California  92123-4282