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

This study is currently recruiting participants.

Verified by Children's Hospital, San Diego, May 2005

Sponsored by:	Children's Hospital, San Diego
Information provided by:	Children's Hospital, San Diego
ClinicalTrials.gov Identifier:	NCT00292513

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)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
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

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

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

Children's Hospital, San Diego

Investigators

Principal Investigator:

Bari B Cunningham, MD

Children's Hospital, San Diego

More Information

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

Study placed in the following topic categories:

Facies
Pilomatrixoma
Cysts
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on January 14, 2009