Clinical trial · Interventional
Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold
Proof of Concept Study Assessing Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Mode of application to be reconsidered by Sponsor
Summary
Brief summary (as posted)
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
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 |
|---|---|---|---|
| SmartMatrix dermal replacement scaffold | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SmartMatrix scaffold
- description
- SmartMatrix dermal replacement scaffold
- interventionNames
- Device: SmartMatrix dermal replacement scaffold
Primary outcomes (1)
- measure
- Safety
- timeFrame
- 6 months
- description
- incidence of adverse events related to use of wound scaffold
Secondary outcomes (4)
- measure
- wound healing
- timeFrame
- 6 months, 12 months
- description
- measurement of time to 100% re-epithelialisation of wound
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available