Skin Lesion
Conditions
Brief 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.
Interventions
DEVICEExternally Implantable Tissue Expansion Device
Will Apply Externally Implantable Tissue Expansion Device for 2 Days
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surface area (in cm2) of subject's scar | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Treating physicians will note any adverse effects | 3 months |
Countries
United States
Outcome results
None listed