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NCT00798798 Clinical Trial

Effect of Externally Implantable Tissue Expansion Device on Scar Length

Skin Lesion Clinical Trial

Official title:
Effect of Externally Implantable Tissue Expansion Device on Scar Length

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00798798
Other study ID # MA-STU2545
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 2008
Est. completion date October 2010

Study information
Verified date December 2021
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess whether brief use of an externally implantable tissue expansion device following excisional skin cancer surgery will significantly reduce the diameter of the final wound defect, and hence the length of the final linear primary closure. The secondary objective is to assess the functional benefits, if any, associated with use of the tissue expander.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria - Subjects ages 18-80 years old - Subjects who are undergoing an excision of a large cutaneous lesion - Subjects with an immediate post-excision wound defect at least 2.5 cm in diameter - Subjects undergoing surgery on the trunk or extremities - The subject has willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator. - Subjects who are willing to undergo no other treatments for the scars for the duration of the study. Exclusion Criteria - Subjects with scalp wounds - Subjects who are unable to understand the protocol or give informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Externally Implantable Tissue Expansion Device
Will Apply Externally Implantable Tissue Expansion Device for 2 Days

Locations
Country Name City State
United States Northwestern University Dermatology Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Surface area (in cm2) of subject's scar 3 months
Secondary Treating physicians will note any adverse effects 3 months
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