Effectiveness and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix for Wound Healing After MOHS Surgery

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• History of wound abnormalities or any other findings that would impede participation in the trial, as per PI discretion.

Egyéb

• Post-operative defects superficial and deemed not appropriate for second intention healing, as determined by the investigator.
• Pregnant, lactating/breast feeding, or planning a pregnancy. A negative urine pregnancy test will be required at screening for female subjects of childbearing potential; a woman will be considered to be of childbearing potential unless she has had a tubal ligation, total hysterectomy, bilateral oophorectomy, or is postmenopausal (without a menstrual period for at least one year).
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• Between 18 and 85 years of age, inclusive
• Subject in good health, or with stable treated medical condition, as determined by the investigator.
• Scheduled to undergo elective Mohs surgery to remove a single biopsy-proven basal cell carcinoma (BCC), squamous cell carcinoma (SCC), or melanoma in situ (MIS) lesion on the head, face, or upper extremity that is amenable to Mohs surgery.
• Tumor location and size meets the following criteria for immediate MMS:
  • Largest total surface area of ≤16cm2 and smallest total surface area per PI discretion.
  • Depth with majority of tumor excision at least to subcutaneous tissue.
  • Adequate dermal contract with graft.
• Willing and able to complete and comply with procedures, protocol requirements, and instructions, including self-performed wound care and completion of all required visits.
• Able to speak, read, write, and understand the language of the informed consent form (ICF) and study questionnaires.
• Willingness and ability to understand the risks, benefits, and alternatives to participation, and give informed consent.
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