Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold

Smart Matrix Limited

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Squamous Cell Carcinoma

Basal Cell Carcinoma

Treatments

Device: SmartMatrix dermal replacement scaffold

Study type

Interventional

Funder types

Other

Identifiers

NCT02059252

SML001/13

Details and patient eligibility

About

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).

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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