Effectiveness and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix for Wound Healing After MOHS Surgery
NCT ID: NCT06919809
Last Updated: 2025-09-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
16 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-08-08
Study Completion Date
2026-02-28
Brief Summary
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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).
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).
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Detailed Description
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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.
Conditions
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Wound Healing After MMS Surgery
BCC - Basal Cell Carcinoma
SCC - Squamous Cell Carcinoma
Melanoma In Situ
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Recipient of the X A-DERM™ mADM
The participants will receive the X A-DERM™ mADM following MMS for removal of BCC, SCC, or MIS lesions in the face, head, or upper extremities. 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.
Group Type
EXPERIMENTAL
A microsurfaced ADM (acellular dermal matrix)
Intervention Type
DEVICE
X A-DERM™ ADM has been resurfaced (Microsurfaced) instead of currently utilized smooth surface reconstructive grafts. Microsurfacing of regenerative tissue grafts increases the surface area at the graft-to-host interface and results in quicker absorption of blood into the graft, greater cellular infiltration, improved seal and wound bed preparedness.
Interventions
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A microsurfaced ADM (acellular dermal matrix)
X A-DERM™ ADM has been resurfaced (Microsurfaced) instead of currently utilized smooth surface reconstructive grafts. Microsurfacing of regenerative tissue grafts increases the surface area at the graft-to-host interface and results in quicker absorption of blood into the graft, greater cellular infiltration, improved seal and wound bed preparedness.
Intervention Type
DEVICE
Other Intervention Names
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X A-DERM™ ADM
Eligibility Criteria
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Inclusion Criteria
1. Between 18 and 85 years of age, inclusive
2. Subject in good health, or with stable treated medical condition, as determined by the investigator.
3. 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.
4. 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.
5. Willing and able to complete and comply with procedures, protocol requirements, and instructions, including self-performed wound care and completion of all required visits.
6. Able to speak, read, write, and understand the language of the informed consent form (ICF) and study questionnaires.
7. Willingness and ability to understand the risks, benefits, and alternatives to participation, and give informed consent.
\-
1. History of wound abnormalities or any other findings that would impede participation in the trial, as per PI discretion.
2. Post-operative defects superficial and deemed not appropriate for second intention healing, as determined by the investigator.
3. 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).
\-
2. Subject in good health, or with stable treated medical condition, as determined by the investigator.
3. 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.
4. 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.
5. Willing and able to complete and comply with procedures, protocol requirements, and instructions, including self-performed wound care and completion of all required visits.
6. Able to speak, read, write, and understand the language of the informed consent form (ICF) and study questionnaires.
7. Willingness and ability to understand the risks, benefits, and alternatives to participation, and give informed consent.
\-
1. History of wound abnormalities or any other findings that would impede participation in the trial, as per PI discretion.
2. Post-operative defects superficial and deemed not appropriate for second intention healing, as determined by the investigator.
3. 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).
\-
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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CellTherX
INDUSTRY
Sponsor Role
collaborator
McGuire Institute
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Mike Drake
Role: STUDY_DIRECTOR
CellTherX
Aaron Farberg, MD
Role: PRINCIPAL_INVESTIGATOR
Bare Dermatology
Locations
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Bare Dermatology
Rockwall, Texas, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Related Links
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https://celltherx.com/
Related Info
Other Identifiers
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CTX2025-01
Identifier Type: -
Identifier Source: org_study_id
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