BCC - Basal Cell Carcinoma, Melanoma In Situ, SCC - Squamous Cell Carcinoma, Wound Healing After MMS Surgery
Conditions
Keywords
MMS, BCC, SCC, MIS, Melanoma In Situ, Wound Healing, Scar Quality, Wound Management, Wound Cosmetics
Brief 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).
Detailed description
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.
Interventions
DEVICEA 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.
Sponsors
McGuire Institute
CellTherX
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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). \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effectiveness of X A-DERM™ mADM on clinician- and patient-based assessments and objective measurements of wound healing and scar quality. | Visit 1(Day 0), Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 30), and Visit 5 (Day 60). | This will be done by capturing digital photographs. Digital photographs of the wound bed site will be acquired pre- and post-placement of the mADM perioperatively and at follow-up visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effectiveness of X A-DERM™ mADM on objective metrics of wound healing based on physical measurements as well as subjective assessments on wound management, pain, functional outcomes, quality of life, and cosmetic appearance | Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 30), and Visit 5 (Day 60). | This will be done by completing clinician reported outcomes. The first clinician reported outcome tool used is the Visual Analog Scale (VAS) for scar appearance. It is completed by making a mark across the line corresponding to the clinician observation between the statements at each of the extremes. The associated "lines" encapsulate a spectrum of scar appearance with "excellent" on one end and "poor" on the opposite. |
Countries
United States
Contacts
STUDY_DIRECTORMike Drake
CellTherX
PRINCIPAL_INVESTIGATORAaron Farberg, MD
Bare Dermatology
Outcome results
None listed