Effect of Externally Implantable Tissue Expansion Device on Scar Length

Northwestern University

Status: Withdrawn

Conditions: Skin Lesion

Treatments: Device: Externally Implantable Tissue Expansion Device

Study type: Interventional

Funder types: Other

Identifiers

NCT00798798

MA-STU2545

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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0 participants in 1 patient group

Implantable Tissue Expansion Device

Experimental group

Description:

Will apply externally implantable tissue expansion device for 2 days

Treatment:

Device: Externally Implantable Tissue Expansion Device