Phase
Condition
N/ATreatment
DuoDerm
MAP Wound Matrix
Clinical Study ID
Ages > 22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Willing to undergo the written informed consent process prior to enrollment in thisstudy.
At least 22 years of age at screening.
Has non-melanoma skin cancer and be scheduled for skin cancer surgery with Mohsmicrographic surgery on a location suitable for secondary intention healing.
Resulting surgical wound after Mohs micrographic surgery must be at least 1 cm andno more than 4 cm in diameter (or surface area of at least 0.8 cm2 and no more than 12.6 cm2).
Resulting surgical wound after Mohs micrographic surgery must be full thickness.
Willing to return for all required follow-up visits.
Willing to follow the instructions of the Principal Investigator.
Exclusion
Exclusion Criteria:
_ Has a confirmed diagnosis of clinically significant peripheral neuropathy.
Has uncontrolled Type I or Type II diabetes and HbA1c values greater than 8.0%within the last 6 months.
Has a known infection in the area of the Mohs micrographic surgery.
Has a known allergy to any of the components of the TT101 Device.
Is an active daily cigarette smoker.
Is pregnant or lactating.
Is a woman of child-bearing potential who is unwilling to avoid pregnancy or use anappropriate form of birth control (adequate birth control methods are defined as:topical, oral, implantable, or injectable contraceptives; spermicide in conjunctionwith a barrier such as a condom or diaphragm; IUD; or surgical sterilization ofpartner).
Has clinical evidence of Peripheral Vascular Disease (PVD) in the form of grade 2pitting Edema or higher.
Has been diagnosed with a surgical or wound site infection within the last 6-months.
Has been diagnosed with chronic ulcer or wound within the last 12- months.
Has a remote active infection concurrent with having the Mohs micrographic surgery.
Per Investigator's discretion the subject is not appropriate for inclusion in thetrial.
Study Design
Connect with a study center
Cal Coast Dermatology
Encino, California 91436
United StatesActive - Recruiting
Laser and Skin Surgery Center of Indiana
Indianapolis, Indiana 46260
United StatesActive - Recruiting
Studies in Dermatology
Cypress, Texas 77429
United StatesActive - Recruiting
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