Study Assessing the Safety and Performance of Smart Matrix®
Primary Purpose
Basal Cell Carcinoma, Squamous Cell Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Smart Matrix scaffold
Sponsored by
About this trial
This is an interventional treatment trial for Basal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Poole General Hospital
- Broomfield Hospital
- Wythenshawe Hospital, Manchester University NHS Foundation Trust
- The Queen Victoria Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Smart Matrix scaffold
Arm Description
Smart Matrix dermal replacement scaffold
Outcomes
Primary Outcome Measures
Incidence of infection and device-related adverse events
Safety
Secondary Outcome Measures
Complete wound healing
Measurement of time to >95% re-epithelisiation of wound
Cosmesis
Assessment of scar formation and development using the Patient and Observer Scar Assessment Scale (POSAS)
Cosmesis
Assessment of scar formation and development using the Vancouver Scar Scale (VSS)
Pain at dressing change
Pain at dressing change assessed using a 10 cm VAS
Dressing change
Number of dressing changes will be recorded
Full Information
NCT ID
NCT03742726
First Posted
October 23, 2018
Last Updated
February 18, 2021
Sponsor
Smart Matrix Limited
1. Study Identification
Unique Protocol Identification Number
NCT03742726
Brief Title
Study Assessing the Safety and Performance of Smart Matrix®
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 12, 2018 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smart Matrix Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma, Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smart Matrix scaffold
Arm Type
Experimental
Arm Description
Smart Matrix dermal replacement scaffold
Intervention Type
Device
Intervention Name(s)
Smart Matrix scaffold
Intervention Description
Smart Matrix dermal replacement scaffold
Primary Outcome Measure Information:
Title
Incidence of infection and device-related adverse events
Description
Safety
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Complete wound healing
Description
Measurement of time to >95% re-epithelisiation of wound
Time Frame
24 weeks, 52 weeks
Title
Cosmesis
Description
Assessment of scar formation and development using the Patient and Observer Scar Assessment Scale (POSAS)
Time Frame
24 weeks, 52 weeks
Title
Cosmesis
Description
Assessment of scar formation and development using the Vancouver Scar Scale (VSS)
Time Frame
24 weeks, 52 weeks
Title
Pain at dressing change
Description
Pain at dressing change assessed using a 10 cm VAS
Time Frame
24 weeks, 52 weeks
Title
Dressing change
Description
Number of dressing changes will be recorded
Time Frame
24 weeks, 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baljit Dheansa, MBBS FRCS
Organizational Affiliation
Queen Victoria Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poole General Hospital
City
Poole
State/Province
Dorset
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Broomfield Hospital
City
Chelmsford
State/Province
Essex
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
Wythenshawe Hospital, Manchester University NHS Foundation Trust
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
The Queen Victoria Hospital NHS Foundation Trust
City
East Grinstead
State/Province
West Sussex
ZIP/Postal Code
RH19 3DZ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study Assessing the Safety and Performance of Smart Matrix®
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