Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold

Phase 1

Terminated

• Conditions: Squamous Cell Carcinoma; Basal Cell Carcinoma
• Interventions: Device: SmartMatrix dermal replacement scaffold

• Registration Number: NCT02059252
• Lead Sponsor: Smart Matrix Limited

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-11
• Study Start: 2014-08
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-01
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SmartMatrix scaffold	SmartMatrix dermal replacement scaffold	SmartMatrix dermal replacement scaffold

Primary Outcome Measures

Name	Time	Method
Safety	6 months	incidence of adverse events related to use of wound scaffold

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Queen Victoria Hospital NHS Foundation Trust; 🇬🇧 East Grinstead, United Kingdom

The Welsh Centre for Burns and Plastic Surgery; 🇬🇧 Swansea, United Kingdom