Smart Matrix, version number 1.0, date 30 March 2018
Research type
Research Study
Full 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
IRAS ID
245749
Contact name
Lilian Hook
Contact email
Sponsor organisation
Smart Matrix Limited
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
-, -
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Indication(s) for Use: Full-thickness wounds, such as those following excision of basal cell carcinoma or squamous cell carcinoma, and surgically excised full- and partial thickness burn wounds. Smart Matrix should be used in conjunction with standard wound care regimes.
Smart Matrix is a medical device intended for the management of wounds, including reconstructive treatment of full- and partial-thickness wounds and first and second degree burns, without the use of a split thickness skin graft in adults.
Patients who meet the inclusion and exclusion criteria will be considered eligible for the study.
From first enrolment to last patient last visit, the study duration is expected to be approximately 2 years, with 1 year of enrolment.
Patients will undergo physical examination, vital signs, serum pregnancy test (women of childbearing potential only), clinical laboratory analytes, photography/measurement of wound, assessment of pain at dressing change and between visits, scar assessment.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
18/WM/0143
Date of REC Opinion
26 Jun 2018
REC opinion
Further Information Favourable Opinion