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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by Rady Children's Hospital, San Diego.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rady Children's Hospital, San Diego
ClinicalTrials.gov Identifier:
NCT00292513
First received: February 15, 2006
Last updated: NA
Last verified: May 2005
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Rady Children's Hospital, San Diego:
  Eligibility
Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00292513     History of Changes
Other Study ID Numbers: Dermabond Study
Study First Received: February 15, 2006
Last Updated: February 15, 2006
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on March 02, 2015