Effectiveness and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix for Wound Healing Aft… (NCT06919809) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix for Wound Healing After MOHS Surgery
United States16 participantsStarted 2025-08-08
Plain-language 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).
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
âś“. Between 18 and 85 years of age, inclusive
âś“. Subject in good health, or with stable treated medical condition, as determined by the investigator.
âś“. 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.
âś“. Tumor location and size meets the following criteria for immediate MMS:
âś“. Willing and able to complete and comply with procedures, protocol requirements, and instructions, including self-performed wound care and completion of all required visits.
âś“. Able to speak, read, write, and understand the language of the informed consent form (ICF) and study questionnaires.
âś“. Willingness and ability to understand the risks, benefits, and alternatives to participation, and give informed consent.
Exclusion criteria
âś•. History of wound abnormalities or any other findings that would impede participation in the trial, as per PI discretion.
What they're measuring
1
To evaluate the effectiveness of X A-DERM™ mADM on clinician- and patient-based assessments and objective measurements of wound healing and scar quality.
To evaluate the effectiveness of X A-DERM™ mADM on clinician- and patient-based assessments and objective measurements of wound healing and scar quality.
âś•. Post-operative defects superficial and deemed not appropriate for second intention healing, as determined by the investigator.
âś•. 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).