Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold

NCT02059252 | Terminated Phase 1 DMC

• 1 other identifier: SML001/13
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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).

Conditions

Basal Cell Carcinoma; Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Safety

  incidence of adverse events related to use of wound scaffold

  6 months

Secondary Outcomes (4)

• wound healing

  6 months, 12 months

• cosmesis

  6 months, 12 months

• pain at dressing change

  3 months

• dressing change

  3 months

Study Arms (1)

SmartMatrix scaffold

EXPERIMENTAL

SmartMatrix dermal replacement scaffold

Device: SmartMatrix dermal replacement scaffold

Interventions

SmartMatrix dermal replacement scaffold DEVICE

SmartMatrix dermal replacement scaffold

SmartMatrix scaffold

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Smart Matrix Limited: lead
• Welsh Centre for Burns and Plastic Surgery, Swansea, UK: collaborator
• Queen Victoria Hospital NHS Foundation Trust: collaborator

Study Sites (2)

Queen Victoria Hospital NHS Foundation Trust

East Grinstead, RH19 3DZ, United Kingdom

Location

The Welsh Centre for Burns and Plastic Surgery

Swansea, SA6 6NL, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms, Squamous Cell

Study Officials

• Iain Whitaker, Professor

  The Welsh Centre for Burns and Plastic Surgery, Morriston Hospital, Swansea, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: February 11, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 4, 2016

Record last verified: 2016-04

Locations

GB (2)