Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold

Proof of Concept Study Assessing Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold

SmartMatrix™ is a single layer dermal replacement scaffold for full thickness skin replacement. 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 ingress and rapid growth of new blood vessels.

This proof of concept study will involve patients with surgical wounds resulting from the excision of basal cell carcinoma (BCC) and squamous cell carcinoma SCC).

Study Overview

• Status: Terminated
• Conditions: Basal Cell Carcinoma; Squamous Cell Carcinoma
• Intervention / Treatment: Device: SmartMatrix dermal replacement scaffold

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • East Grinstead, United Kingdom, RH19 3DZ
    • Queen Victoria Hospital Nhs Foundation Trust
  • Swansea, United Kingdom, SA6 6NL
    • The Welsh Centre for Burns and Plastic Surgery

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Male or female, at least 18 years of age
• Suspected or histologically proven BCC or SCC
• Suspected or histologically proven BCC or SCC ≥1cm ≤3cm in diameter on either leg
• Expected defect following surgery ≥3cm, ≤6cm in diameter
• Patient or authorised representative able to comprehend and sign the Informed Consent prior to enrolment in the study

Exclusion Criteria:

• Aged <18 years of age
• Pregnant or lactating females
• Skin lesion >4cm in diameter or size that will result in post-surgical defect >6cm in diameter
• Lesion located over joint, i.e. ankle or knee
• Patient who are smokers
• Diabetic patients
• Patients diagnosed with peripheral vascular disease or venous stasis
• Patients receiving regular systemic steroids
• Patients who are immuno-compromised (either acquired or congenital)
• Patients with a 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 about to be treated with Smart Matrix
• Concurrent participation in another experimental intervention or drug study
• 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: SmartMatrix scaffold; SmartMatrix dermal replacement scaffold	Device: SmartMatrix dermal replacement scaffold; SmartMatrix dermal replacement scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	incidence of adverse events related to use of wound scaffold	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound healing	measurement of time to 100% re-epithelialisation of wound	6 months, 12 months
cosmesis	patient and surgeon assessment of scar formation and development using recognised assessment scores	6 months, 12 months
pain at dressing change	pain at dressing change will be assessed using a 10cm VAS	3 months
dressing change	frequency and number of dressing changes will be recorded	3 months

Collaborators and Investigators

• Sponsor: Smart Matrix Limited
• Collaborators: Welsh Centre for Burns and Plastic Surgery, Swansea, UK; Queen Victoria Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Iain Whitaker, Professor, The Welsh Centre for Burns and Plastic Surgery, Morriston Hospital, Swansea, UK

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: December 11, 2013
• First Submitted That Met QC Criteria: February 10, 2014
• First Posted (Estimate): February 11, 2014

Study Record Updates

• Last Update Posted (Estimate): April 4, 2016
• Last Update Submitted That Met QC Criteria: April 1, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell
• Other Study ID Numbers: SML001/13