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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well a new treatment, X A-DERM™ (a microsurfaced acellular dermal matrix), aids in wound healing and improved scar formation after skin cancer surgery. It targets individuals undergoing Mohs surgery to remove specific skin cancers—basal cell carcinoma, squamous cell carcinoma, or melanoma in situ—on the face, head, or upper limbs. Participants will receive the X A-DERM™ graft post-surgery and will visit the doctor four additional times for wound assessments. Ideal candidates for this trial are those with planned Mohs surgery for these cancers in the specified areas. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in wound healing and scar formation.

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.

What prior data suggests that the X A-DERM™ mADM is safe for wound healing after skin cancer surgery?

Research has shown that the X A-DERM™ mADM is generally safe for patients undergoing treatment for wound healing. In studies, the wound area decreased significantly, indicating faster healing with this treatment. While specific side effects are not detailed, testing in humans suggests reasonable safety. Additionally, the trial aims to gather more safety information, so participants will be closely monitored to address any potential issues promptly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The X A-DERM™ Microsurfaced Acellular Dermal Matrix is unique because it uses an advanced dermal graft to aid in wound healing after skin cancer surgery. Unlike traditional methods that might rely on basic sutures or skin grafts, this treatment involves a specialized material that integrates with the body's tissues to support healing. Researchers are excited because this approach could accelerate the healing process and improve cosmetic outcomes, particularly for challenging areas like the face and head. By providing a scaffold for new tissue growth, X A-DERM™ may offer a more effective and aesthetically pleasing solution compared to standard treatments.

What evidence suggests that X A-DERM™ is effective for wound healing after skin cancer surgery?

Research has shown that X A-DERM™ mADM, which participants in this trial will receive, can enhance wound healing and improve scar appearance after skin cancer surgery. In studies, patients using this treatment experienced better wound healing and scar appearance after 60 days. This treatment provides a structure that supports the body's natural repair process. Surgeons have observed improved appearance in skin treated with this material, and patients generally express satisfaction with the results. Early evidence suggests that X A-DERM™ could be a promising option for individuals undergoing skin cancer surgery. ^{2 3 4 6 7}

Who Is on the Research Team?

Mike Drake

Principal Investigator

CellTherX

Aaron Farberg, MD

Principal Investigator

Bare Dermatology

Are You a Good Fit for This Trial?

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:

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

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

Exclusion Criteria

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06919809

Effectiveness and Safety of X A-DERM™ Microsurfaced ... 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 ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06919809/effectiveness-and-safety-of-x-a-dermtm-microsurfaced-acellular-dermal-matrix-for-wound-healing-after-mohs-surgery?activelyRecruiting=false&page=378&id=25005&slug=carcinoma

Effectiveness and Safety of X A-DERM™ Microsurfaced Acellular ... 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 ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/596797

Effectiveness and Safety of X A-DERM™ Microsurfaced ... 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 ...

4. withpower.com withpower.com/trial/x-a-derm-for-wound-healing-after-skin-cancer-surgery-11a9e

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

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12480496/

A randomized, controlled, double-blinded trial on the effects of ... Subjective survey showed that surgeons viewed ADM co-grafted skin as more favorable to the surgeons and that patients did not complain of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06919809

Effectiveness and Safety of X A-DERM™ Microsurfaced ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10031240/

Evaluation of wound healing effects of micronized acellular ... The post‐wound area was significantly reduced by 59.10% compared with the baseline, indicating an excellent wound healing effect. In a recent ...