Basal Cell CarcinomaPhase 1/2NCT02059252
Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold
A Phase 1/2 study testing SmartMatrix dermal replacement scaffold in people with Basal Cell Carcinoma and Squamous Cell Carcinoma, run by Smart Matrix Limited at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma, Squamous Cell Carcinoma
- What is being tested?
- SmartMatrix dermal replacement scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Aug 2014to Mar 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Queen Victoria Hospital NHS Foundation Trust
East Grinstead, RH19 3DZ
The Welsh Centre for Burns and Plastic Surgery
Swansea, SA6 6NL
About this study
Official title: Proof of Concept Study Assessing Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold
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).
- Conditions
- Basal Cell Carcinoma, Squamous Cell Carcinoma
- Being tested
- SmartMatrix dermal replacement scaffold
- Medical subject headings
- Carcinoma, Basal Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartMatrix dermal replacement scaffoldDevice
SmartMatrix dermal replacement scaffold
| Study group | Role | What they receive |
|---|---|---|
| SmartMatrix scaffold | Experimental | SmartMatrix dermal replacement scaffold Receives: Device: SmartMatrix dermal replacement scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
incidence of adverse events related to use of wound scaffold
Measured: 6 months
Secondary outcomes (4)
wound healing
measurement of time to 100% re-epithelialisation of wound
Measured: 6 months, 12 months
cosmesis
patient and surgeon assessment of scar formation and development using recognised assessment scores
Measured: 6 months, 12 months
pain at dressing change
pain at dressing change will be assessed using a 10cm VAS
Measured: 3 months
dressing change
frequency and number of dressing changes will be recorded
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Mode of application to be reconsidered by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smart Matrix Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Welsh Centre for Burns and Plastic Surgery, Swansea, UK, Queen Victoria Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Iain Whitaker, Professor, Principal investigator, The Welsh Centre for Burns and Plastic Surgery, Morriston Hospital, Swansea, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059252
- Sponsor's protocol ID
- SML001/13
- Status last verified
- Apr 2016
- First submitted
- 11 Dec 2013
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Study Assessing Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold
- ClinicalTrials.gov ID
- NCT02059252
- Acronym / sponsor ID
- SML001/13
- Conditions
- Basal Cell Carcinoma, Squamous Cell Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Mode of application to be reconsidered by Sponsor
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Smart Matrix LimitedUniversity, hospital or other
- Collaborators
- Welsh Centre for Burns and Plastic Surgery, Swansea, UK, Queen Victoria Hospital NHS Foundation Trust
- Study start
- Aug 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SmartMatrix scaffold | Experimental | Device: SmartMatrix dermal replacement scaffoldSmartMatrix dermal replacement scaffold |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartMatrix dermal replacement scaffoldSmartMatrix dermal replacement scaffold | Device | SmartMatrix scaffold |
Primary outcome
Safety
Time frame: 6 months
incidence of adverse events related to use of wound scaffold
4 secondary outcomes
wound healing
Time frame: 6 months, 12 months
cosmesis
Time frame: 6 months, 12 months
pain at dressing change
Time frame: 3 months
dressing change
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Mode of application to be reconsidered by Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iain Whitaker, Professor principal investigator
The Welsh Centre for Burns and Plastic Surgery, Morriston Hospital, Swansea, UK
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SmartMatrix dermal replacement scaffold in people with Basal Cell Carcinoma and Squamous Cell Carcinoma, run by Smart Matrix Limited at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Mode of application to be reconsidered by Sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016.