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

February 15, 2006 updated by: Rady Children's Hospital, San Diego

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Recruiting
        • Children's Hospital San Diego
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rady Children's Hospital, San Diego

Investigators

  • Principal Investigator: Bari B Cunningham, MD, Rady Children's Hospital, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 15, 2006

First Submitted That Met QC Criteria

February 15, 2006

First Posted (Estimate)

February 16, 2006

Study Record Updates

Last Update Posted (Estimate)

February 16, 2006

Last Update Submitted That Met QC Criteria

February 15, 2006

Last Verified

May 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dermabond Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cyst of Face, Neck or Shoulder

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