Study Assessing the Safety and Performance of Smart Matrix®

Study Assessing the Safety and Performance of Smart Matrix® Dermal Replacement Scaffold in the Treatment of Full-Thickness Wounds Arising From Surgical Excision of Basal Cell or Squamous Cell Carcinomas in Male and Female Adult Patients

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.

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