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 range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. Willingness and ability to understand the risks, benefits, and alternatives to participation, and give informed consent.
Exclusion criteria
. History of wound abnormalities or any other findings that would impede participation in the trial, as per PI discretion.
. 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).