Study Assessing the Safety and Performance of Smart Matrix®

Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03742726
• Other study ID #: SML002/18
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 12, 2018
• Est. completion date: January 2022

Study information

• Verified date: February 2021
• Source: Smart Matrix Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: January 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma

Intervention

Device:
• Smart Matrix scaffold
Smart Matrix dermal replacement scaffold

Locations

Country	Name	City	State
United Kingdom	Broomfield Hospital	Chelmsford	Essex
United Kingdom	The Queen Victoria Hospital NHS Foundation Trust	East Grinstead	West Sussex
United Kingdom	Wythenshawe Hospital, Manchester University NHS Foundation Trust	Manchester	Greater Manchester
United Kingdom	Poole General Hospital	Poole	Dorset

Sponsors (1)

Lead Sponsor	Collaborator
Smart Matrix Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of infection and device-related adverse events	Safety	24 weeks
Secondary	Complete wound healing	Measurement of time to >95% re-epithelisiation of wound	24 weeks, 52 weeks
Secondary	Cosmesis	Assessment of scar formation and development using the Patient and Observer Scar Assessment Scale (POSAS)	24 weeks, 52 weeks
Secondary	Cosmesis	Assessment of scar formation and development using the Vancouver Scar Scale (VSS)	24 weeks, 52 weeks
Secondary	Pain at dressing change	Pain at dressing change assessed using a 10 cm VAS	24 weeks, 52 weeks
Secondary	Dressing change	Number of dressing changes will be recorded	24 weeks, 52 weeks