Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-03-31

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).

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Detailed Description

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Conditions

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Basal Cell Carcinoma Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SmartMatrix scaffold

SmartMatrix dermal replacement scaffold

Group Type EXPERIMENTAL

SmartMatrix dermal replacement scaffold

Intervention Type DEVICE

SmartMatrix dermal replacement scaffold

Interventions

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SmartMatrix dermal replacement scaffold

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No