Clinical trial · Interventional
Study Assessing the Safety and Performance of Smart Matrix®
Study Assessing the Safety and Performance of Smart Matrix® Dermal Replacement Scaffold in the Treatment of Full-Thickness Wounds Arising From Surgical Excision of Basal Cell or Squamous Cell Carcinomas in Male and Female Adult Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Smart Matrix scaffold | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Smart Matrix scaffold
- description
- Smart Matrix dermal replacement scaffold
- interventionNames
- Device: Smart Matrix scaffold
Primary outcomes (1)
- measure
- Incidence of infection and device-related adverse events
- timeFrame
- 24 weeks
- description
- Safety
Secondary outcomes (5)
- measure
- Complete wound healing
- timeFrame
- 24 weeks, 52 weeks
- description
- Measurement of time to \>95% re-epithelisiation of wound
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Patients on anti-coagulants * Known history of human immunodeficiency virus infection, Hepatitis B, Hepatitis C, or human papillomavirus * 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 to be treated with Smart Matrix * Patients who have acute or active Charcot's disease or a significant neuropathic disease * Patients who have suspected signs of systemic or local infection, as determined by the Investigator based on clinical parameters * History of hypersensitivity or allergic reaction to any of the constituents of Smart Matrix * History of hypersensitivity or allergic reaction to unknown allergens * Patients who have been treated with tissue engineered skin or a biological therapy within 30 days (or as described on labelling) of Screening * Patients who, in the opinion of the Investigator, have co-morbidities and/or an underlying condition that would impact wound healing * Participation in a clinical study involving an investigational medication or investigational device within the last 30 days or 5 half-lives * Unwilling or unable, in the opinion of the Investigator, to comply with the protocol * Unwilling or unable to provide informed consent
References
Publications (0)
Data not yet available