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:

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 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:

Genetics Home Reference related topics: pilomatricoma

Genetic and Rare Diseases Information Center resources: Pilomatrixoma

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 (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

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


ClinicalTrials.gov Identifier:	NCT00292513 History of Changes
Other Study ID Numbers:	Dermabond Study
Study First Received:	February 15, 2006
Last Updated:	February 15, 2006

Additional relevant MeSH terms:


Pilomatrixoma Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms

ClinicalTrials.gov processed this record on August 23, 2017

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