Basal Cell Carcinoma, Squamous Cell Carcinoma
Conditions
Brief summary
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).
Interventions
DEVICESmartMatrix dermal replacement scaffold
SmartMatrix dermal replacement scaffold
Sponsors
Welsh Centre for Burns and Plastic Surgery, Swansea, UK
Queen Victoria Hospital NHS Foundation Trust
Smart Matrix Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 6 months | incidence of adverse events related to use of wound scaffold |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| wound healing | 6 months, 12 months | measurement of time to 100% re-epithelialisation of wound |
| cosmesis | 6 months, 12 months | patient and surgeon assessment of scar formation and development using recognised assessment scores |
| pain at dressing change | 3 months | pain at dressing change will be assessed using a 10cm VAS |
| dressing change | 3 months | frequency and number of dressing changes will be recorded |
Countries
United Kingdom
Outcome results
None listed