Status:
RECRUITING
Effectiveness and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix for Wound Healing After MOHS Surgery
Lead Sponsor:
McGuire Institute
Collaborating Sponsors:
CellTherX
Conditions:
Wound Healing After MMS Surgery
BCC - Basal Cell Carcinoma
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 B...
Detailed 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 t...
Eligibility Criteria
Inclusion
- Subjects must meet all the following criteria to be entered into the study:
- 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.
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Exclusion
- Subjects who meet the above inclusion criteria will be eligible for the study, unless they present with any of the following:
- 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).
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Key Trial Info
Start Date :
August 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06919809
Start Date
August 8 2025
End Date
February 28 2026
Last Update
September 25 2025
Active Locations (1)
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1
Bare Dermatology
Rockwall, Texas, United States, 75032