Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold

NCT02059252 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2016-04-04

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

SmartMatrix dermal replacement scaffold

SmartMatrix dermal replacement scaffold

Sponsors & Collaborators

  • Welsh Centre for Burns and Plastic Surgery, Swansea, UK

    collaborator UNKNOWN
  • Queen Victoria Hospital NHS Foundation Trust

    collaborator OTHER_GOV
  • Smart Matrix Limited

    lead OTHER

Principal Investigators

  • Iain Whitaker, Professor · The Welsh Centre for Burns and Plastic Surgery, Morriston Hospital, Swansea, UK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02059252 on ClinicalTrials.gov