Study Assessing the Safety and Performance of Smart Matrix®

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Basal Cell Carcinoma; Squamous Cell Carcinoma
• Intervention / Treatment: Device: Smart Matrix scaffold

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Dorset
    • Poole, Dorset, United Kingdom, BH15 2JB
      • Poole General Hospital
  • Essex
    • Chelmsford, Essex, United Kingdom, CM1 7ET
      • Broomfield Hospital
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M23 9LT
      • Wythenshawe Hospital, Manchester University NHS Foundation Trust
  • West Sussex
    • East Grinstead, West Sussex, United Kingdom, RH19 3DZ
      • The Queen Victoria Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smart Matrix scaffold; Smart Matrix dermal replacement scaffold	Device: Smart Matrix scaffold; Smart Matrix dermal replacement scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of infection and device-related adverse events	Safety	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete wound healing	Measurement of time to >95% re-epithelisiation of wound	24 weeks, 52 weeks
Cosmesis	Assessment of scar formation and development using the Patient and Observer Scar Assessment Scale (POSAS)	24 weeks, 52 weeks
Cosmesis	Assessment of scar formation and development using the Vancouver Scar Scale (VSS)	24 weeks, 52 weeks
Pain at dressing change	Pain at dressing change assessed using a 10 cm VAS	24 weeks, 52 weeks
Dressing change	Number of dressing changes will be recorded	24 weeks, 52 weeks

Collaborators and Investigators

• Sponsor: Smart Matrix Limited
• Investigators: Principal Investigator: Baljit Dheansa, MBBS FRCS, Queen Victoria Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2018
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Squamous Cell; Carcinoma, Basal Cell
• Other Study ID Numbers: SML002/18

Drug and device information, study documents

• 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