study assessing the safety and performance of smart matrix®

Conditions: Basal Cell Carcinoma; Squamous Cell Carcinoma

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.


Eligibility criteria:
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 \ 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