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TerminatedNCT02059252Updated Apr 4, 2016

Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold

A Phase 1/2 interventional study of SmartMatrix dermal replacement scaffold in Basal Cell Carcinoma and Squamous Cell Carcinoma, sponsored by Smart Matrix Limited. Terminated at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-04.

Sponsored by Smart Matrix Limited · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Mode of application to be reconsidered by Sponsor
Phase
Phase 1/2
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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).

02

Conditions studied

  • Basal Cell Carcinoma
  • Squamous Cell Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 5 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Smart Matrix Limited is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    SmartMatrix scaffold

    SmartMatrix dermal replacement scaffold

    Device: SmartMatrix dermal replacement scaffold

Interventions

  • DeviceSmartMatrix dermal replacement scaffold

    SmartMatrix dermal replacement scaffold

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What researchers measure

Primary outcomes

  1. Safety

    incidence of adverse events related to use of wound scaffold

    Time frame: 6 months

Secondary outcomes

  1. wound healing

    measurement of time to 100% re-epithelialisation of wound

    Time frame: 6 months, 12 months

  2. cosmesis

    patient and surgeon assessment of scar formation and development using recognised assessment scores

    Time frame: 6 months, 12 months

  3. pain at dressing change

    pain at dressing change will be assessed using a 10cm VAS

    Time frame: 3 months

  4. dressing change

    frequency and number of dressing changes will be recorded

    Time frame: 3 months

07

Study locations

2 sites
  • Queen Victoria Hospital NHS Foundation Trust
    East Grinstead, RH19 3DZ, United Kingdom
  • The Welsh Centre for Burns and Plastic Surgery
    Swansea, SA6 6NL, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02059252
Lead sponsor
Smart Matrix Limited
Collaborators
Welsh Centre for Burns and Plastic Surgery, Swansea, UK, Queen Victoria Hospital NHS Foundation Trust
Responsible party
Sponsor
First posted
Feb 11, 2014
Start date
Aug 2014
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Apr 4, 2016

Study contacts

Iain Whitaker, Professor
principal investigator · The Welsh Centre for Burns and Plastic Surgery, Morriston Hospital, Swansea, UK

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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