Study Assessing the Safety and Performance of Smart Matrix®

Smart Matrix Limited

Status

Unknown

Conditions

Squamous Cell Carcinoma

Basal Cell Carcinoma

Treatments

Device: Smart Matrix scaffold

Study type

Interventional

Funder types

Other

Identifiers

NCT03742726

SML002/18

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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