X A-DERM™ for Wound Healing After Skin Cancer Surgery

Overseen By Kathy Donkin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGuire Institute

Disqualifiers: Pregnancy, Wound abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Immediate post-surgery

16 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial investigator to understand any potential interactions with the study treatment.

Is X A-DERM™ safe for use in humans?

Acellular dermal matrices (ADMs), like X A-DERM™, have been used in various surgeries, including skin cancer and breast reconstruction. While they are generally considered safe, some studies report complications such as infection and wound issues. However, in skin cancer surgeries, ADMs have shown low complication rates and are a viable alternative to traditional skin grafts. ^{1 2 3 4 5}

How is the treatment X A-DERM™ different from other treatments for wound healing after skin cancer surgery?

X A-DERM™ is unique because it uses a microsurfaced acellular dermal matrix, which is a skin substitute that doesn't require a donor site for skin grafting, making it a less invasive option for patients. This treatment can be particularly beneficial for those who cannot undergo general anesthesia or have other health concerns that make traditional skin grafts challenging. ^{1 3 6 7 8}

What is the purpose of this trial?

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).

Research Team

Mike Drake

Principal Investigator

CellTherX

Aaron Farberg, MD

Principal Investigator

Bare Dermatology

Eligibility Criteria

This trial is for individuals who have undergone MOHS surgery to remove lesions from Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC), or Melanoma In Situ (MIS) on their face, head, or upper limbs. Participants should be in good health and willing to follow the study's procedures.

Inclusion Criteria

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

I am willing and able to follow all study requirements, including self-care and visits.

Able to speak, read, write, and understand the language of the informed consent form (ICF) and study questionnaires

Exclusion Criteria

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

My surgical wound is surface-level and needs more than natural healing.

History of wound abnormalities or any other findings that would impede participation in the trial, as per PI discretion

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MMS surgery and receive the X A-DERM™ mADM graft at the surgical site

Immediate post-surgery

1 visit (in-person)

Follow-up

Participants are monitored for wound healing and scar formation through clinical assessments and patient-reported outcomes

60 days

4 visits (in-person) on Day 7, Day 14, Day 30, and Day 60

Treatment Details

Interventions

• X A-DERM™ Microsurfaced Acellular Dermal Matrix

Trial Overview The trial studies the X A-DERM™ mADM's effectiveness in wound healing and scar improvement after MOHS surgery. Patients will receive this grafting treatment post-surgery and attend follow-up visits for wound assessment through pictures, clinical evaluations, and personal feedback.

Participant Groups

Group I: Recipient of the X A-DERM™ mADM Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

McGuire Institute

Lead Sponsor

Trials

7

Recruited

390+

CellTherX

Industry Sponsor

Trials

2

Recruited

30+

Findings from Research

In a study of 46 women undergoing implant-based breast reconstruction, the use of acellular dermal matrix (ADM) did not significantly increase the rate of early complications or implant loss compared to standard procedures, suggesting it is a safe option.

While ADM was associated with a higher rate of implant loss, all cases were linked to prior radiotherapy, indicating that the complications may be more related to patient history than the ADM itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early complications and implant loss in implant-based breast reconstruction with and without acellular dermal matrix (Tecnoss Protexa®): a comparative study. Potter, S., Chambers, A., Govindajulu, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Human Acellular Dermal Matrix Is a Viable Alternative to Autologous Skin Graft in Patients with Cutaneous Malignancy. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Non-integrated acellular dermal matrix in breast reconstruction: a case report. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term outcome of xenogenic dermal matrix implantation in immunocompetent rats. [2003]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical Factors Influencing the Outcomes of an Acellular Dermal Matrix for Skin Cancer Treatment: A Retrospective Study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Early complications and implant loss in implant-based breast reconstruction with and without acellular dermal matrix (Tecnoss Protexa®): a comparative study. [2022]

6. China pubmed.ncbi.nlm.nih.gov

[Experience of applying acellular dermal matrix in the head and neck tumor surgery]. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The expanded role of extracellular matrix patch in malignant and non-malignant chest wall reconstruction in thoracic surgery. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Acellular Dermal Matrix: Treating Periocular Melanoma in a Patient with Xeroderma Pigmentosa. [2020]