NCT06919809Completed
Effectiveness and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix for Wound Healing After MOHS Surgery
Efficacy and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix (mADM) for Enhancing Wound Healing Following Mohs Micrographic Surgery (MMS)
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 28 Mar 2025
- Start date
- 8 Aug 2025
- Primary completion date
- 9 Jan 2026
- Lead sponsor
- McGuire Institute
- Diseases
- Melanoma
- NCT number
- NCT06919809
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From 8 Aug 2025 to the primary completion date, 9 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of wound abnormalities or any other findings that would impede participation in the trial, as per PI discretion.
Other
- 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).
- \-
Who the study is looking for
- 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:
- 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.
- 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.
- Willingness and ability to understand the risks, benefits, and alternatives to participation, and give informed consent.
- \-
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bare Dermatology Coordinator of this site? Confirm its status | Rockwall | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.