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Effectiveness and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix for Wound Healing After MOHS Surgery

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Subjects must meet all the following criteria to be entered into the study: 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.
  • -

    Exclusion Criteria:

    Subjects who meet the above inclusion criteria will be eligible for the study, unless they present with any of the following: 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). -

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06919809
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 McGuire Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Mike Drake
Principal Investigator Affiliation CellTherX
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Wound Healing After MMS Surgery, BCC - Basal Cell Carcinoma, SCC - Squamous Cell Carcinoma, Melanoma In Situ
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Interventions

Device: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bare Dermatology, Rockwall, Texas

Status

Address

Bare Dermatology

Rockwall, Texas, 75032

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