Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold

Study Overview
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Brief Summary
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SmartMatrix™ is a single layer dermal replacement scaffold for full thickness skin replacement. 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 ingress and rapid growth of new blood vessels. This proof of concept study will involve patients with surgical wounds resulting from the excision of basal cell carcinoma (BCC) and squamous cell carcinoma SCC).

Official Title
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Proof of Concept Study Assessing Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold

Conditions
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Basal Cell Carcinoma, Squamous Cell Carcinoma

Intervention / Treatment
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* Device: SmartMatrix dermal replacement scaffold


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, at least 18 years of age Suspected or histologically proven BCC or SCC Suspected or histologically proven BCC or SCC ≥1cm ≤3cm in diameter on either leg Expected defect following surgery ≥3cm, ≤6cm in diameter Patient or authorised representative able to comprehend and sign the Informed Consent prior to enrolment in the study Exclusion Criteria: Aged <18 years of age Pregnant or lactating females Skin lesion >4cm in diameter or size that will result in post-surgical defect >6cm in diameter Lesion located over joint, i.e. ankle or knee Patient who are smokers Diabetic patients Patients diagnosed with peripheral vascular disease or venous stasis Patients receiving regular systemic steroids Patients who are immuno-compromised (either acquired or congenital) Patients with a 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 about to be treated with Smart Matrix Concurrent participation in another experimental intervention or drug study Unwilling or unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 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: SmartMatrix scaffold<br>SmartMatrix dermal replacement scaffold | Device: SmartMatrix dermal replacement scaffold<br>* SmartMatrix dermal replacement scaffold<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | incidence of adverse events related to use of wound scaffold | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing | measurement of time to 100% re-epithelialisation of wound | 6 months, 12 months | 
| cosmesis | patient and surgeon assessment of scar formation and development using recognised assessment scores | 6 months, 12 months | 
| pain at dressing change | pain at dressing change will be assessed using a 10cm VAS | 3 months | 
| dressing change | frequency and number of dressing changes will be recorded | 3 months |