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

Launched by MCGUIRE INSTITUTE · Apr 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a product called X A-DERM™ microsurfaced acellular dermal matrix (mADM) to help wounds heal better and reduce scarring after Mohs surgery. Mohs surgery is a procedure used to remove certain types of skin cancer, including basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma in situ (MIS). The trial's main goal is to see if using X A-DERM™ will lead to improved wound healing and scar appearance 60 days after the surgery.

To be eligible for the trial, participants need to be between 18 and 85 years old, in good health, and scheduled for Mohs surgery to remove a specific type of skin cancer lesion on their face, head, or upper limbs. Participants will receive the graft after their surgery and will need to return for four follow-up visits, where the doctors will check on their healing progress through pictures and assessments. It’s important that participants are willing to follow the study's instructions and understand the process, including any risks and benefits of joining the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria: Subjects must meet all the following criteria to be entered into the study:
• • 1. Between 18 and 85 years of age, inclusive
• • 2. Subject in good health, or with stable treated medical condition, as determined by the investigator.
• • 3. 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.
• 4. 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.
• • 5. Willing and able to complete and comply with procedures, protocol requirements, and instructions, including self-performed wound care and completion of all required visits.
• • 6. Able to speak, read, write, and understand the language of the informed consent form (ICF) and study questionnaires.
• • 7. Willingness and ability to understand the risks, benefits, and alternatives to participation, and give informed consent.
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• Exclusion Criteria: Subjects who meet the above inclusion criteria will be eligible for the study, unless they present with any of the following:
• • 1. History of wound abnormalities or any other findings that would impede participation in the trial, as per PI discretion.
• • 2. Post-operative defects superficial and deemed not appropriate for second intention healing, as determined by the investigator.
• • 3. 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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