Study Assessing the Safety and Performance of Smart Matrix®

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/A

Clinical Study ID

NCT03742726
SML002/18
  • Ages 18-90
  • All Genders

Study 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

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 Kingdom

    Site Not Available

  • Broomfield Hospital

    Chelmsford, Essex CM1 7ET
    United Kingdom

    Site Not Available

  • Wythenshawe Hospital, Manchester University NHS Foundation Trust

    Manchester, Greater Manchester M23 9LT
    United Kingdom

    Site Not Available

  • The Queen Victoria Hospital NHS Foundation Trust

    East Grinstead, West Sussex RH19 3DZ
    United Kingdom

    Site Not Available

  • Morriston Hospital

    Swansea, SA6 6NL
    United Kingdom

    Site Not Available

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