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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Skin Lesion

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