NCT03742726

Brief Summary

Smart Matrix is a sterile, single layer dermal replacement scaffold. 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 invasion.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

2.7 years

First QC Date

October 23, 2018

Last Update Submit

February 18, 2021

Conditions

Basal Cell CarcinomaSquamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Incidence of infection and device-related adverse events

    Safety

    24 weeks

Secondary Outcomes (5)

  • Complete wound healing

    24 weeks, 52 weeks

  • Cosmesis

    24 weeks, 52 weeks

  • Cosmesis

    24 weeks, 52 weeks

  • Pain at dressing change

    24 weeks, 52 weeks

  • Dressing change

    24 weeks, 52 weeks

Study Arms (1)

Smart Matrix scaffold

EXPERIMENTAL

Smart Matrix dermal replacement scaffold

Device: Smart Matrix scaffold

Interventions

Smart Matrix scaffoldDEVICE

Smart Matrix dermal replacement scaffold

Smart Matrix scaffold

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, between 18 years and 90 years of age, inclusive
  • Suspected or histologically proven BCC or SCC, where treatment with a skin graft would be considered following excision of the lesion
  • Expected wound following excision surgery between 2 cm and 5 cm in diameter, inclusive
  • Negative urine or serum pregnancy test in females of childbearing potential who do not plan to become pregnant during the study
  • Able and willing to comply with the protocol and necessary wound care/follow-up
  • Patient or legally authorised representative (LAR) able to comprehend and sign informed consent prior to enrolment in the study

You may not qualify if:

  • Aged \<18 years or \>90 years of age
  • Body mass index \>=35 kg/m2
  • Patients who are pregnant or breastfeeding females, or female patients who plan to become pregnant during the study
  • Patients with Stage 3 or higher BCC or SCC
  • Skin lesion of a size that will result in an expected post-surgical wound \>5 cm in diameter
  • Lesion located over a joint
  • Lesion located in an area in which scarring is already present
  • Lesion located on the face
  • Patients with a chronically inflammatory dermatological condition
  • History of smoking within 1 year prior to Screening
  • Use of any nicotine-containing product during the study, from Screening and through the last follow-up visit
  • Patients with Type 1 diabetes mellitus, newly diagnosed diabetes mellitus (within 3 months prior to Screening), or poorly controlled Type 2 diabetes mellitus
  • Diagnosis of peripheral vascular disease or venous stasis in proximity to the lesion to be treated
  • Presence of significant immunodeficiency or an immunocompromised condition
  • Patients who are currently receiving systemic steroid medications or other medications that might impede wound healing
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Poole General Hospital

Poole, Dorset, BH15 2JB, United Kingdom

Location

Broomfield Hospital

Chelmsford, Essex, CM1 7ET, United Kingdom

Location

Wythenshawe Hospital, Manchester University NHS Foundation Trust

Manchester, Greater Manchester, M23 9LT, United Kingdom

Location

The Queen Victoria Hospital NHS Foundation Trust

East Grinstead, West Sussex, RH19 3DZ, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Basal CellCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellNeoplasms, Squamous Cell

Study Officials

  • Baljit Dheansa, MBBS FRCS

    Queen Victoria Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2018

First Posted

November 15, 2018

Study Start

October 12, 2018

Primary Completion

July 1, 2021

Study Completion

January 1, 2022

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

GB(4)