RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Efficacy and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix (mADM) for Enhancing Wound Healing Following Mohs Micrographic Surgery (MMS)

Quick Facts

Study Start:2025-08-08
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06919809

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Between 18 and 85 years of age, inclusive
  2. 2. Subject in good health, or with stable treated medical condition, as determined by the investigator.
  3. 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. 4. Tumor location and size meets the following criteria for immediate MMS:
  5. * Largest total surface area of ≤16cm2 and smallest total surface area per PI discretion.
  6. * Depth with majority of tumor excision at least to subcutaneous tissue.
  7. * Adequate dermal contract with graft.
  8. 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.
  9. 6. Able to speak, read, write, and understand the language of the informed consent form (ICF) and study questionnaires.
  10. 7. Willingness and ability to understand the risks, benefits, and alternatives to participation, and give informed consent.
  1. 1. History of wound abnormalities or any other findings that would impede participation in the trial, as per PI discretion.
  2. 2. Post-operative defects superficial and deemed not appropriate for second intention healing, as determined by the investigator.
  3. 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).

Contacts and Locations

Study Contact

Kathy Donkin
CONTACT
16155048180
k.donkin@themcguireinstitute.org
Rick Heard
CONTACT
3612123934
r.heard@themcguireinstute.org

Principal Investigator

Mike Drake
STUDY_DIRECTOR
CellTherX
Aaron Farberg, MD
PRINCIPAL_INVESTIGATOR
Bare Dermatology

Study Locations (Sites)

Bare Dermatology
Rockwall, Texas, 75032
United States

Collaborators and Investigators

Sponsor: McGuire Institute

  • Mike Drake, STUDY_DIRECTOR, CellTherX
  • Aaron Farberg, MD, PRINCIPAL_INVESTIGATOR, Bare Dermatology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-08
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2025-08-08
Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

  • MMS
  • BCC
  • SCC
  • MIS
  • Melanoma In Situ
  • Wound Healing
  • Scar Quality
  • Wound Management
  • Wound Cosmetics

Additional Relevant MeSH Terms

  • Wound Healing After MMS Surgery
  • BCC - Basal Cell Carcinoma
  • SCC - Squamous Cell Carcinoma
  • Melanoma In Situ