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Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold

Primary Purpose

Basal Cell Carcinoma, Squamous Cell Carcinoma

Status
Terminated
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
SmartMatrix dermal replacement scaffold
Sponsored by
Smart Matrix Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Victoria Hospital NHS Foundation Trust
  • The Welsh Centre for Burns and Plastic Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SmartMatrix scaffold

Arm Description

SmartMatrix dermal replacement scaffold

Outcomes

Primary Outcome Measures

Safety
incidence of adverse events related to use of wound scaffold

Secondary Outcome Measures

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

Full Information

First Posted
December 11, 2013
Last Updated
April 1, 2016
Sponsor
Smart Matrix Limited
Collaborators
Welsh Centre for Burns and Plastic Surgery, Swansea, UK, Queen Victoria Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02059252
Brief Title
Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold
Official Title
Proof of Concept Study Assessing Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Mode of application to be reconsidered by Sponsor
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smart Matrix Limited
Collaborators
Welsh Centre for Burns and Plastic Surgery, Swansea, UK, Queen Victoria Hospital NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma, Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SmartMatrix scaffold
Arm Type
Experimental
Arm Description
SmartMatrix dermal replacement scaffold
Intervention Type
Device
Intervention Name(s)
SmartMatrix dermal replacement scaffold
Intervention Description
SmartMatrix dermal replacement scaffold
Primary Outcome Measure Information:
Title
Safety
Description
incidence of adverse events related to use of wound scaffold
Time Frame
6 months
Secondary Outcome Measure Information:
Title
wound healing
Description
measurement of time to 100% re-epithelialisation of wound
Time Frame
6 months, 12 months
Title
cosmesis
Description
patient and surgeon assessment of scar formation and development using recognised assessment scores
Time Frame
6 months, 12 months
Title
pain at dressing change
Description
pain at dressing change will be assessed using a 10cm VAS
Time Frame
3 months
Title
dressing change
Description
frequency and number of dressing changes will be recorded
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iain Whitaker, Professor
Organizational Affiliation
The Welsh Centre for Burns and Plastic Surgery, Morriston Hospital, Swansea, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Victoria Hospital NHS Foundation Trust
City
East Grinstead
ZIP/Postal Code
RH19 3DZ
Country
United Kingdom
Facility Name
The Welsh Centre for Burns and Plastic Surgery
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

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Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold

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