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COMPLETED
NCT06919809
NA

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

Sponsor: McGuire Institute

View on ClinicalTrials.gov

Summary

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)

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2025-08-08

Completion Date

2026-03-06

Last Updated

2026-04-24

Healthy Volunteers

No

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.

Locations (1)

Bare Dermatology

Rockwall, Texas, United States