Last updated: February 18, 2021
Sponsor: Smart Matrix Limited
Overall Status: Active - Not Recruiting
Phase
N/A
Condition
Warts
Human Papilloma Virus (Hpv)
Cancer/tumors
Treatment
N/AClinical Study ID
NCT03742726
SML002/18
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 wouldbe 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 notplan 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 signinformed consent prior to enrolment in the study
Exclusion
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 tobecome 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 indiameter
- 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 throughthe last follow-up visit
- Patients with Type 1 diabetes mellitus, newly diagnosed diabetes mellitus (within 3months prior to Screening), or poorly controlled Type 2 diabetes mellitus
- Diagnosis of peripheral vascular disease or venous stasis in proximity to the lesionto be treated
- Presence of significant immunodeficiency or an immunocompromised condition
- Patients who are currently receiving systemic steroid medications or other medicationsthat might impede wound healing
- Patients on anti-coagulants
- Known history of human immunodeficiency virus infection, Hepatitis B, Hepatitis C, orhuman papillomavirus
- Known coagulopathy (either acquired or congenital) but not including patients onaspirin or other anti-platelet therapy
- Patients who have received radiotherapy treatment to the area to be treated with SmartMatrix
- Patients who have acute or active Charcot's disease or a significant neuropathicdisease
- Patients who have suspected signs of systemic or local infection, as determined by theInvestigator based on clinical parameters
- History of hypersensitivity or allergic reaction to any of the constituents of SmartMatrix
- History of hypersensitivity or allergic reaction to unknown allergens
- Patients who have been treated with tissue engineered skin or a biological therapywithin 30 days (or as described on labelling) of Screening
- Patients who, in the opinion of the Investigator, have co-morbidities and/or anunderlying condition that would impact wound healing
- Participation in a clinical study involving an investigational medication orinvestigational 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
Study Design
Total Participants: 32
Study Start date:
October 12, 2018
Estimated Completion Date:
January 31, 2022
Connect with a study center
Poole General Hospital
Poole, Dorset BH15 2JB
United KingdomSite Not Available
Broomfield Hospital
Chelmsford, Essex CM1 7ET
United KingdomSite Not Available
Wythenshawe Hospital, Manchester University NHS Foundation Trust
Manchester, Greater Manchester M23 9LT
United KingdomSite Not Available
The Queen Victoria Hospital NHS Foundation Trust
East Grinstead, West Sussex RH19 3DZ
United KingdomSite Not Available
Morriston Hospital
Swansea, SA6 6NL
United KingdomSite Not Available
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