Basal Cell CarcinomaNCT03742726
Study Assessing the Safety and Performance of Smart Matrix®
A study testing Smart Matrix scaffold in people with Basal Cell Carcinoma and Squamous Cell Carcinoma, run by Smart Matrix Limited at 4 sites in United Kingdom.
Trial summary
Smart Matrix is a sterile, single layer dermal replacement scaffold. 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 invasion. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Basal Cell Carcinoma, Squamous Cell Carcinoma
- What is being tested?
- Smart Matrix scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 12 Oct 2018to Jan 2022
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, between 18 years and 90 years of age, inclusive
- Suspected or histologically proven BCC or SCC, where treatment with a skin graft would be considered following excision of the lesion
- Expected wound following excision surgery between 2 cm and 5 cm in diameter, inclusive
- Negative urine or serum pregnancy test in females of childbearing potential who do not plan to become pregnant during the study
- Able and willing to comply with the protocol and necessary wound care/follow-up
- Patient or legally authorised representative (LAR) able to comprehend and sign informed consent prior to enrolment in the study
Who cannot join
- Aged <18 years or >90 years of age
- Body mass index >=35 kg/m2
- Patients who are pregnant or breastfeeding females, or female patients who plan to become pregnant during the study
- Patients with Stage 3 or higher BCC or SCC
- Skin lesion of a size that will result in an expected post-surgical wound >5 cm in diameter
- Lesion located over a joint
Show all 28Show fewer
- Lesion located in an area in which scarring is already present
- Lesion located on the face
- Patients with a chronically inflammatory dermatological condition
- History of smoking within 1 year prior to Screening
- Use of any nicotine-containing product during the study, from Screening and through the last follow-up visit
- Patients with Type 1 diabetes mellitus, newly diagnosed diabetes mellitus (within 3 months prior to Screening), or poorly controlled Type 2 diabetes mellitus
- Diagnosis of peripheral vascular disease or venous stasis in proximity to the lesion to be treated
- Presence of significant immunodeficiency or an immunocompromised condition
- Patients who are currently receiving systemic steroid medications or other medications that might impede wound healing
- Patients on anti-coagulants
- Known history of human immunodeficiency virus infection, Hepatitis B, Hepatitis C, or human papillomavirus
- 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 to be treated with Smart Matrix
- Patients who have acute or active Charcot's disease or a significant neuropathic disease
- Patients who have suspected signs of systemic or local infection, as determined by the Investigator based on clinical parameters
- History of hypersensitivity or allergic reaction to any of the constituents of Smart Matrix
- History of hypersensitivity or allergic reaction to unknown allergens
- Patients who have been treated with tissue engineered skin or a biological therapy within 30 days (or as described on labelling) of Screening
- Patients who, in the opinion of the Investigator, have co-morbidities and/or an underlying condition that would impact wound healing
- Participation in a clinical study involving an investigational medication or investigational device within the last 30 days or 5 half-lives
- Unwilling or unable, in the opinion of the Investigator, to comply with the protocol
- Unwilling or unable to provide informed consent
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Broomfield Hospital
Chelmsford, Essex, CM1 7ET
The Queen Victoria Hospital NHS Foundation Trust
East Grinstead, West Sussex, RH19 3DZ
Wythenshawe Hospital, Manchester University NHS Foundation Trust
Manchester, Greater Manchester, M23 9LT
Poole General Hospital
Poole, Dorset, BH15 2JB
About this study
Official title: Study Assessing the Safety and Performance of Smart Matrix® Dermal Replacement Scaffold in the Treatment of Full-Thickness Wounds Arising From Surgical Excision of Basal Cell or Squamous Cell Carcinomas in Male and Female Adult Patients
Smart Matrix is a sterile, single layer dermal replacement scaffold. 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 invasion.
- Conditions
- Basal Cell Carcinoma, Squamous Cell Carcinoma
- Being tested
- Smart Matrix 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.
Smart Matrix scaffoldDevice
Smart Matrix dermal replacement scaffold
| Study group | Role | What they receive |
|---|---|---|
| Smart Matrix scaffold | Experimental | Smart Matrix dermal replacement scaffold Receives: Device: Smart Matrix scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infection and device-related adverse events
Safety
Measured: 24 weeks
Secondary outcomes (5)
Complete wound healing
Measurement of time to >95% re-epithelisiation of wound
Measured: 24 weeks, 52 weeks
Cosmesis
Assessment of scar formation and development using the Patient and Observer Scar Assessment Scale (POSAS)
Measured: 24 weeks, 52 weeks
Cosmesis
Assessment of scar formation and development using the Vancouver Scar Scale (VSS)
Measured: 24 weeks, 52 weeks
Pain at dressing change
Pain at dressing change assessed using a 10 cm VAS
Measured: 24 weeks, 52 weeks
Dressing change
Number of dressing changes will be recorded
Measured: 24 weeks, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start12 Oct 2018
- Primary completionJul 2021 (estimated)
- Study completionJan 2022 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smart Matrix Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baljit Dheansa, MBBS FRCS, Principal investigator, Queen Victoria Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742726
- Sponsor's protocol ID
- SML002/18
- Status last verified
- Feb 2021
- First submitted
- 23 Oct 2018
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Assessing the Safety and Performance of Smart Matrix® Dermal Replacement Scaffold in the Treatment of Full-Thickness Wounds Arising From Surgical Excision of Basal Cell or Squamous Cell Carcinomas in Male and Female Adult Patients
- ClinicalTrials.gov ID
- NCT03742726
- Acronym / sponsor ID
- SML002/18
- Conditions
- Basal Cell Carcinoma, Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Smart Matrix LimitedUniversity, hospital or other
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 15 Nov 2018 (actual)
- 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.
Smart Matrix is a sterile, single layer dermal replacement scaffold. 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 invasion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smart Matrix scaffold | Experimental | Device: Smart Matrix scaffoldSmart Matrix dermal replacement scaffold |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, between 18 years and 90 years of age, inclusive
- Suspected or histologically proven BCC or SCC, where treatment with a skin graft would be considered following excision of the lesion
- Expected wound following excision surgery between 2 cm and 5 cm in diameter, inclusive
- Negative urine or serum pregnancy test in females of childbearing potential who do not plan to become pregnant during the study
- Able and willing to comply with the protocol and necessary wound care/follow-up
Key exclusion criteria (28 listed)
- Aged <18 years or >90 years of age
- Body mass index >=35 kg/m2
- Patients who are pregnant or breastfeeding females, or female patients who plan to become pregnant during the study
- Patients with Stage 3 or higher BCC or SCC
- Skin lesion of a size that will result in an expected post-surgical wound >5 cm in diameter
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 |
|---|---|---|
| Smart Matrix scaffoldSmart Matrix dermal replacement scaffold | Device | Smart Matrix scaffold |
Primary outcome
Incidence of infection and device-related adverse events
Time frame: 24 weeks
Safety
5 secondary outcomes
Complete wound healing
Time frame: 24 weeks, 52 weeks
Cosmesis
Time frame: 24 weeks, 52 weeks
Cosmesis
Time frame: 24 weeks, 52 weeks
Pain at dressing change
Time frame: 24 weeks, 52 weeks
Dressing change
Time frame: 24 weeks, 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
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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.
Baljit Dheansa, MBBS FRCS principal investigator
Queen Victoria Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Matrix scaffold in people with Basal Cell Carcinoma and Squamous Cell Carcinoma, run by Smart Matrix Limited at 4 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 6 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
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?
Incidence of infection and device-related adverse events (time frame: 24 weeks). 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 21 Feb 2021.