Wound Healing After MMS SurgeryNCT06919809
Effectiveness and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix for Wound Healing After MOHS Surgery
A study testing A microsurfaced ADM (acellular dermal matrix) in people with Wound Healing After MMS Surgery and BCC - Basal Cell Carcinoma, run by McGuire Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Wound Healing After MMS Surgery, BCC - Basal Cell Carcinoma, SCC - Squamous Cell Carcinoma
- What is being tested?
- A microsurfaced ADM (acellular dermal matrix)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2025to 6 Mar 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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:
- 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.
- 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. -
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). -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix (mADM) for Enhancing Wound Healing Following Mohs Micrographic Surgery (MMS)
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).
Read the 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.
- Conditions
- Wound Healing After MMS Surgery, BCC - Basal Cell Carcinoma, SCC - Squamous Cell Carcinoma, Melanoma In Situ
- Being tested
- A microsurfaced ADM (acellular dermal matrix)
- Keywords
- MMS, BCC, SCC, MIS, Melanoma In Situ, Wound Healing, Scar Quality, Wound Management, Wound Cosmetics
- Medical subject headings
- Carcinoma, Basal Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A microsurfaced ADM (acellular dermal matrix)Device
Also called X A-DERM™ ADM
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: A microsurfaced ADM (acellular dermal matrix) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 30), and Visit 5 (Day 60).
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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").
Measured: 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?
Measured: 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.
Measured: Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 30), and Visit 5 (Day 60).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start8 Aug 2025
- Primary completion9 Jan 2026
- Study completion6 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (87)Papers the sponsor has linked to this study.
- Other trials for Wound Healing After MMS SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGuire Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CellTherX
- Responsible party
- Sponsor
- Investigators
- Mike Drake, Study director, CellTherXAaron Farberg, MD, Principal investigator, Bare Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919809
- Sponsor's protocol ID
- CTX2025-01
- Status last verified
- Jul 2025
- First submitted
- 28 Mar 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This study does not plan to share individual participant data. Results will be published in peer-reviewed journals, with aggregate data only.
Publications
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.
PubMed 27478420Broughton 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.
PubMed 16799372Rubin DB. Multiple imputation for nonresponse in surveys. Hoboken, N.J. ;: Wiley-Interscience; 2004: xxix, 287 p.
Schafer JL. Analysis of Incomplete Multivariate Data: CRC Press; 1997.
Allison PD. Missing Data: SAGE Publications; 2001.
National Research Council (US) Panel on Handling Missing Data in Clinical Trials. The Prevention and Treatment of Missing Data in Clinical Trials. Washington (DC): National Academies Press (US); 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK209904/
PubMed 24983040West BT, Welch KB, Gałecki AT, Gillespie BW. Linear mixed models : a practical guide using statistical software. Boca Raton: CRC Press, Taylor & Francis Group; 2015: xxv, 414 pages.
Goldstein H. Multilevel statistical models. Chichester, West Sussex: Wiley; 2011: xxi, 358 p.
Gilthorpe MS, Dahly DL, Tu YK, Kubzansky LD, Goodman E. Challenges in modelling the random structure correctly in growth mixture models and the impact this has on model mixtures. J Dev Orig Health Dis. 2014 Jun;5(3):197-205. doi: 10.1017/S2040174414000130.
PubMed 24901659EMA. Guideline On Adjustment for Baseline Covariates in Clinical Trials (EMA/CHMP/295050/2013). In: Use EMACfMPfH, ed.: European Medicines Agency Amsterdam, 2013.
Cheng J, Edwards LJ, Maldonado-Molina MM, Komro KA, Muller KE. Real longitudinal data analysis for real people: building a good enough mixed model. Stat Med. 2010 Feb 20;29(4):504-20. doi: 10.1002/sim.3775.
PubMed 20013937Maxwell SE, Kelley K, Rausch JR. Sample size planning for statistical power and accuracy in parameter estimation. Annu Rev Psychol. 2008;59:537-63. doi: 10.1146/annurev.psych.59.103006.093735.
PubMed 17937603Phillips A, Abellan-Andres J, Soren A, Bretz F, Fletcher C, France L, Garrett A, Harris R, Kjaer M, Keene O, Morgan D, O'Kelly M, Roger J. Estimands: discussion points from the PSI estimands and sensitivity expert group. Pharm Stat. 2017 Jan;16(1):6-11. doi: 10.1002/pst.1745. Epub 2016 Mar 21.
PubMed 26997517Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802.
PubMed 23268518FDA. Guidance for Industry - Non-Inferiority Clinical Trials to Establish Effectiveness. No. Food and Drug Administration, 2016. (U.S. Department of Health and Human Services publication