Basal Cell Carcinoma, Squamous Cell Carcinoma
Conditions
Brief summary
Smart Matrix is a sterile, single layer dermal replacement scaffold. The scaffold consists of a porous matrix of cross-linked human fibrin plus alginate that has been designed and optimised to facilitate wound closure and healing through cellular invasion.
Interventions
DEVICESmart Matrix scaffold
Smart Matrix dermal replacement scaffold
Sponsors
Smart Matrix Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, between 18 years and 90 years of age, inclusive * Suspected or histologically proven BCC or SCC, where treatment with a skin graft would be considered following excision of the lesion * Expected wound following excision surgery between 2 cm and 5 cm in diameter, inclusive * Negative urine or serum pregnancy test in females of childbearing potential who do not plan to become pregnant during the study * Able and willing to comply with the protocol and necessary wound care/follow-up * Patient or legally authorised representative (LAR) able to comprehend and sign informed consent prior to enrolment in the study
Exclusion criteria
* Aged \<18 years or \>90 years of age * Body mass index \>=35 kg/m2 * Patients who are pregnant or breastfeeding females, or female patients who plan to become pregnant during the study * Patients with Stage 3 or higher BCC or SCC * Skin lesion of a size that will result in an expected post-surgical wound \>5 cm in diameter * Lesion located over a joint * Lesion located in an area in which scarring is already present * Lesion located on the face * Patients with a chronically inflammatory dermatological condition * History of smoking within 1 year prior to Screening * Use of any nicotine-containing product during the study, from Screening and through the last follow-up visit * Patients with Type 1 diabetes mellitus, newly diagnosed diabetes mellitus (within 3 months prior to Screening), or poorly controlled Type 2 diabetes mellitus * Diagnosis of peripheral vascular disease or venous stasis in proximity to the lesion to be treated * Presence of significant immunodeficiency or an immunocompromised condition * Patients who are currently receiving systemic steroid medications or other medications that might impede wound healing * Patients on anti-coagulants * Known history of human immunodeficiency virus infection, Hepatitis B, Hepatitis C, or human papillomavirus * Known coagulopathy (either acquired or congenital) but not including patients on aspirin or other anti-platelet therapy * Patients who have received radiotherapy treatment to the area to be treated with Smart Matrix * Patients who have acute or active Charcot's disease or a significant neuropathic disease * Patients who have suspected signs of systemic or local infection, as determined by the Investigator based on clinical parameters * History of hypersensitivity or allergic reaction to any of the constituents of Smart Matrix * History of hypersensitivity or allergic reaction to unknown allergens * Patients who have been treated with tissue engineered skin or a biological therapy within 30 days (or as described on labelling) of Screening * Patients who, in the opinion of the Investigator, have co-morbidities and/or an underlying condition that would impact wound healing * Participation in a clinical study involving an investigational medication or investigational device within the last 30 days or 5 half-lives * Unwilling or unable, in the opinion of the Investigator, to comply with the protocol * Unwilling or unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of infection and device-related adverse events | 24 weeks | Safety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete wound healing | 24 weeks, 52 weeks | Measurement of time to \>95% re-epithelisiation of wound |
| Cosmesis | 24 weeks, 52 weeks | Assessment of scar formation and development using the Patient and Observer Scar Assessment Scale (POSAS) |
| Pain at dressing change | 24 weeks, 52 weeks | Pain at dressing change assessed using a 10 cm VAS |
| Dressing change | 24 weeks, 52 weeks | Number of dressing changes will be recorded |
Countries
United Kingdom
Outcome results
None listed