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

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ClinicalTrials.gov Identifier: NCT00292513
Recruitment Status : Unknown
Verified May 2005 by Rady Children's Hospital, San Diego.
Recruitment status was:  Recruiting
First Posted : February 16, 2006
Last Update Posted : February 16, 2006
Sponsor:
Information provided by:
Rady Children's Hospital, San Diego

Study Description
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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
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) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 the National Library of Medicine

Drug Information available for: Dermabond

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   0 Years 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
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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
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Contact: Bari B Cunningham, MD 858-576-1700 ext 4270 bcunningham@chsd.org

Locations
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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
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Principal Investigator: Bari B Cunningham, MD Rady Children's Hospital, San Diego
More Information
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ClinicalTrials.gov Identifier: NCT00292513    
Other Study ID Numbers: Dermabond Study
First Posted: February 16, 2006    Key Record Dates
Last Update Posted: February 16, 2006
Last Verified: May 2005
Additional relevant MeSH terms:
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Pilomatrixoma
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms