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Trial record 2 of 2 for:    "Pilomatrixoma"

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2005 by Rady Children's Hospital, San Diego.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00292513
First Posted: February 16, 2006
Last Update Posted: February 16, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rady Children's Hospital, San Diego
  Purpose
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 Intervention
Cyst of Face, Neck or Shoulder Pilomatrixoma of Face, Neck or Shoulder Device: standard suture (5-0 prolene), topical skin adhesive (dermabond), absorbable suture (5-0 Chromic gut)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rady Children's Hospital, San Diego:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292513


Contacts
Contact: Bari B Cunningham, MD 858-576-1700 ext 4270 bcunningham@chsd.org

Locations
United States, California
Children's Hospital San Diego Recruiting
San Diego, California, United States, 92123
Principal Investigator: Bari B Cunningham, MD         
Sub-Investigator: Sheila F Friedlander, MD         
Sub-Investigator: Lawrence F Eichenfield, MD         
Sub-Investigator: Brandie Roberts, MD         
Sub-Investigator: Magdalene Dohil, MD         
Sponsors and Collaborators
Rady Children's Hospital, San Diego
Investigators
Principal Investigator: Bari B Cunningham, MD Rady Children's Hospital, San Diego
  More Information

ClinicalTrials.gov Identifier: NCT00292513     History of Changes
Other Study ID Numbers: Dermabond Study
First Submitted: February 15, 2006
First Posted: February 16, 2006
Last Update Posted: February 16, 2006
Last Verified: May 2005

Additional relevant MeSH terms:
Pilomatrixoma
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms