Clincosm LogoSign in Get a demo

Clinical Trial Comparing Tissue Adhesive Vs. Absorbable Suture Vs. Non-Absorbable Suture

Sponsor
Rady Children's Hospital, San Diego (Other)
Overall Status
Unknown status
CT.gov ID
NCT00292513
Collaborator
(none)
1
Location

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Device: standard suture (5-0 prolene), topical skin adhesive (dermabond), absorbable suture (5-0 Chromic gut)
 N/A

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 18 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital San Diego San Diego California United States 92123

    Sponsors and Collaborators

    • Rady Children's Hospital, San Diego

    Investigators

    • Principal Investigator: Bari B Cunningham, MD, Rady Children's Hospital, San Diego

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00292513
    Other Study ID Numbers:
    • Dermabond Study
    First Posted:
    Feb 16, 2006
    Last Update Posted:
    Feb 16, 2006
    Last Verified:
    May 1, 2005
    Additional relevant MeSH terms:
    Pilomatrixoma

    Study Results

    No Results Posted as of Feb 16, 2006