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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00292513
Other study ID # Dermabond Study
Secondary ID
Status Recruiting
Phase N/A
First received February 15, 2006
Last updated February 15, 2006

Study information

Verified date May 2005
Source Rady Children's Hospital, San Diego
Contact Bari B Cunningham, MD
Phone 858-576-1700
Email bcunningham@chsd.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Standard suture is superior to both tissue adhesive (2-octyl cyanoacrylate) and absorbable sutures with respect to cosmetic outcome of, complication rate of and parental satisfaction with the closure of low tension facial, neck and shoulder, wounds in children and adolescents


Recruitment information / eligibility

Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A to 18 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Device:
standard suture (5-0 prolene), topical skin adhesive (dermabond), absorbable suture (5-0 Chromic gut)


Locations

Country Name City State
United States Children's Hospital San Diego San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Rady Children's Hospital, San Diego

Country where clinical trial is conducted

United States,