Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold

Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02059252
• Other study ID #: SML001/13
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: December 11, 2013
• Last updated: April 1, 2016
• Start date: August 2014
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Smart Matrix Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma

Intervention

Device:
• SmartMatrix dermal replacement scaffold
SmartMatrix dermal replacement scaffold

Locations

Country	Name	City	State
United Kingdom	Queen Victoria Hospital NHS Foundation Trust	East Grinstead
United Kingdom	The Welsh Centre for Burns and Plastic Surgery	Swansea

Sponsors (3)

Lead Sponsor	Collaborator
Smart Matrix Limited	Queen Victoria Hospital NHS Foundation Trust, Welsh Centre for Burns and Plastic Surgery, Swansea, UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	incidence of adverse events related to use of wound scaffold	6 months	Yes
Secondary	wound healing	measurement of time to 100% re-epithelialisation of wound	6 months, 12 months	No
Secondary	cosmesis	patient and surgeon assessment of scar formation and development using recognised assessment scores	6 months, 12 months	No
Secondary	pain at dressing change	pain at dressing change will be assessed using a 10cm VAS	3 months	No
Secondary	dressing change	frequency and number of dressing changes will be recorded	3 months	No