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

Last updated: September 22, 2025
Sponsor: McGuire Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Melanoma

Carcinoma

Lung Cancer

Treatment

A microsurfaced ADM (acellular dermal matrix)

Clinical Study ID

NCT06919809
CTX2025-01
  • Ages 18-85
  • All Genders

Study 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 Criteria

Inclusion

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 bythe investigator.

  3. Scheduled to undergo elective Mohs surgery to remove a single biopsy-proven basalcell 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 PIdiscretion.

  • Depth with majority of tumor excision at least to subcutaneous tissue.

  • Adequate dermal contract with graft.

  1. Willing and able to complete and comply with procedures, protocol requirements, andinstructions, including self-performed wound care and completion of all requiredvisits.

  2. Able to speak, read, write, and understand the language of the informed consent form (ICF) and study questionnaires.

  3. Willingness and ability to understand the risks, benefits, and alternatives toparticipation, and give informed consent.

Exclusion

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 participationin the trial, as per PI discretion.

  2. Post-operative defects superficial and deemed not appropriate for second intentionhealing, as determined by the investigator.

  3. Pregnant, lactating/breast feeding, or planning a pregnancy. A negative urinepregnancy test will be required at screening for female subjects of childbearingpotential; a woman will be considered to be of childbearing potential unless she hashad a tubal ligation, total hysterectomy, bilateral oophorectomy, or ispostmenopausal (without a menstrual period for at least one year).

Study Design

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: A microsurfaced ADM (acellular dermal matrix)
Phase:
Study Start date:
August 08, 2025
Estimated Completion Date:
February 28, 2026

Study Description

The objective of this trial is to evaluate the efficacy and safety of X A-DERM™ mADM for enhancing wound healing and improving scar formation following MMS for removal of BCC, SCC, or MIS lesions in the face, head, upper and lower extremities, and trunk in adults 18 to 85 years of age who are scheduled to undergo elective MMS. After complete excision of the tumor and removal of all cancerous tissue, reconstruction immediately follows with placement of the mADM into the defect. Subjects will receive the standard of care for post-op and at-home wound care and will be recalled for a total of 5 in-office visits to evaluate wound healing. This is a single-arm, open-label, prospective clinical trial.

Connect with a study center

  • Bare Dermatology

    Rockwall, Texas 75032
    United States

    Site Not Available

  • Bare Dermatology

    Rockwall 4723406, Texas 4736286 75032
    United States

    Active - Recruiting

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