Study Assessing the Safety and Performance of Smart Matrix®

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Basal Cell Carcinoma, Squamous Cell Carcinoma

Intervention / Treatment
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* Device: Smart Matrix scaffold


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart Matrix scaffold<br>Smart Matrix dermal replacement scaffold | Device: Smart Matrix scaffold<br>* Smart Matrix dermal replacement scaffold<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infection and device-related adverse events | Safety | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete wound healing | Measurement of time to >95% re-epithelisiation of wound | 24 weeks, 52 weeks | 
| Cosmesis | Assessment of scar formation and development using the Patient and Observer Scar Assessment Scale (POSAS) | 24 weeks, 52 weeks | 
| Cosmesis | Assessment of scar formation and development using the Vancouver Scar Scale (VSS) | 24 weeks, 52 weeks | 
| Pain at dressing change | Pain at dressing change assessed using a 10 cm VAS | 24 weeks, 52 weeks | 
| Dressing change | Number of dressing changes will be recorded | 24 weeks, 52 weeks |