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| Name | Class |
|---|---|
| CellTherX | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recipient of the X A-DERM™ mADM | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A microsurfaced ADM (acellular dermal matrix) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effectiveness of X A-DERM™ mADM on clinician- and patient-based assessments and objective measurements of wound healing and scar quality. | 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. | Visit 1(Day 0), Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 30), and Visit 5 (Day 60). |
| To evaluate the effectiveness of X A-DERM™ mADM on clinician- and patient-based assessments and objective measurements of wound healing and scar quality. | This will be done by requesting patients and clinicians to complete POSAS assessments, the Patient and Observer Scar Assessment Scale. The POSAS contains two assessments. The first assessment captures patients' views on scar pain, itchiness, if the scar color is different, if the scar is more stiff, is the thickness of the scar different, and is the scar irregular by ranking their answer from a scale of 1-10. 1 being "no, no complaints" and 10 being "yes, worst imaginable". The second assessment is the clinician's portion. It involves objective scoring based on standardized criteria for characteristics such as vascularity, pigmentation, thickness, relief, pliability, and surface area using a scale from 1-10 1 being "Normal skin" and 10 being "worst scar imaginable". | Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 30), and Visit 5 (Day 60). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria: Subjects must meet all the following criteria to be entered into the study:
Between 18 and 85 years of age, inclusive
Subject in good health, or with stable treated medical condition, as determined by the investigator.
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.
Tumor location and size meets the following criteria for immediate MMS:
Willing and able to complete and comply with procedures, protocol requirements, and instructions, including self-performed wound care and completion of all required visits.
Able to speak, read, write, and understand the language of the informed consent form (ICF) and study questionnaires.
Willingness and ability to understand the risks, benefits, and alternatives to participation, and give informed consent.
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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.
Post-operative defects superficial and deemed not appropriate for second intention healing, as determined by the investigator.
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).
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| Name | Affiliation | Role |
|---|---|---|
| Mike Drake | CellTherX | Study Director |
| Aaron Farberg, MD | Bare Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bare Dermatology | Rockwall | Texas | 75032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27478420 | Background | Commander SJ, Chamata E, Cox J, Dickey RM, Lee EI. Update on Postsurgical Scar Management. Semin Plast Surg. 2016 Aug;30(3):122-8. doi: 10.1055/s-0036-1584824. | |
| 16799372 | Background | Broughton G 2nd, Janis JE, Attinger CE. The basic science of wound healing. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):12S-34S. doi: 10.1097/01.prs.0000225430.42531.c2. |
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This study does not plan to share individual participant data. Results will be published in peer-reviewed journals, with aggregate data only.
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| Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 30), and Visit 5 (Day 60). |
| 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 | This will be done by completing clinician reported outcomes. The second clinician reported outcome tool used is the Manchester Scar Satisfaction Scale (MSSS). It is completed by the clinician evaluating the patient's scar by checking the box of the corresponding characteristic that best matches their assessment for 5 parameters. The first parameter is color (compared to surrounding skin), and the options are perfect, slight mismatch, obvious mismatch, and gross mismatch. The second matte or shiny, and those are the two options. The third is contour, the options being flush with surrounding area, slightly proud (indented), hypertrophic, and keloid. The fourth is distortion with options of none, mild, moderate, and severe. The last parameter is texture with options of normal, just palpable, firm, and hard. | Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 30), and Visit 5 (Day 60). |
| 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 | This will be done by completing patient reported outcomes. The first patient reported outcome tool used is the Visual Analog Scale (VAS) for pain intensity, itching intensity, and cosmetic appearance. It is completed by the patient making a mark across the line corresponding to their observation between the statements at each of the extremes. The associated "lines" encapsulate a spectrum of pain intensity ("no pain" and "worst pain imaginable"), itching intensity ("no itch" and "worst itch imaginable"), and cosmetic appearance ("worst scar" and "best scar"). | Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 30), and Visit 5 (Day 60). |
| 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 | This will be done by completing patient reported outcomes. The second patient reported outcome tool used is the ease of wound care numerical rating scale (NRS). The patient reports on a scale from 0 to 10, where 0 represents "Very Easy" and 10 represents "Impossible," please rate how easy it was for them to care for the wound by themself? | Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 30), and Visit 5 (Day 60). |
| 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 | This will be done by completing patient reported outcomes. The third patient reported outcome tool used is the Skindex-16 questionnaire. The patient will for each of the following questions, make a mark in the box corresponding to your feelings about each of the statements. The scale is "never bothered" to "always bothered" on a 0-6 numerical rank and the various conditions are as follows: itching, burning or stinging, hurting, your skin condition being irritated, the persistence/reoccurrence of your skin condition, worry about your skin condition, the appearance, frustration, embarrassment, being annoyed about your skin condition, feeling depressed about your skin condition, the effects of your skin condition on your desire to be with people, your skin condition making it hard to show affection, the effects of your skin condition on your daily activities, and your skin condition making it hard to work or do what you enjoy. | Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 30), and Visit 5 (Day 60). |
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| 31638524 | Background | Lewis RE, Towery EA, Bhat SG, Ward AJ, Heidel RE, Bielak KM, Simpson HE, McLoughlin JM, Lewis JM. Human Acellular Dermal Matrix Is a Viable Alternative to Autologous Skin Graft in Patients with Cutaneous Malignancy. Am Surg. 2019 Sep 1;85(9):1056-1060. |
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| Background | Castillo J, Fathi R, McIlwee B, Williams K. Before and After Mohs Surgery: What to Expect for Patients. In: (ACMS) ACoMS, ed.: American College of Mohs Surgery Foundation's Mohs Surgeons Leading the Future (MSLF) Program., 2017:https://online.flippingbook.com/view/502707499/. |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018295 | Neoplasms, Basal Cell |
| D018307 | Neoplasms, Squamous Cell |
Not provided
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