Clinical trial NCT03742726: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Basal Cell Carcinoma
Squamous Cell Carcinoma
Lead sponsor: Smart Matrix Limited
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of infection and device-related adverse events
timeFrame: 24 weeks
Secondary outcomes:
measure: Complete wound healing
timeFrame: 24 weeks, 52 weeks
measure: Cosmesis
timeFrame: 24 weeks, 52 weeks
measure: Cosmesis
timeFrame: 24 weeks, 52 weeks
measure: Pain at dressing change
timeFrame: 24 weeks, 52 weeks
measure: Dressing change
timeFrame: 24 weeks, 52 weeks
Other outcomes:
Locations:
city: Poole
country: United Kingdom
facility: Poole General Hospital
state: Dorset
city: Chelmsford
country: United Kingdom
facility: Broomfield Hospital
state: Essex
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital, Manchester University NHS Foundation Trust
state: Greater Manchester
city: East Grinstead
country: United Kingdom
facility: The Queen Victoria Hospital NHS Foundation Trust
state: West Sussex
Study officials:
affiliation: Queen Victoria Hospital
name: Baljit Dheansa, MBBS FRCS
role: PRINCIPAL_INVESTIGATOR
References: