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

Summary

The goal of this single-arm clinical trial is to learn about the effectiveness and safety of the X A-DERM™ mADM in promoting wound healing and improving scar formation after MMS surgery for removing BCC, SCC, or MIS lesions on the face, head, and upper limbs. The main questions it aims to answer are how well this intervention works and what is the safety profile. The primary hypothesis is that the use of X A-DERM™ will result improved wound healing and scar formation after 60 days post-procedure. Participants will undergo MMS surgery to remove BCC, SCC, or MIS lesions, and then will receive the X A-DERM™ mADM graft at the surgical site. Participants will return to the office four additional times for the clinician to collect data on their wound healing. This will involve taking pictures of the wound, conducting clinical assessments (CROs), and documenting the patient's reported outcomes (PROs).

Eligibility

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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Conditions5

Locations1 site

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