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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smart Matrix scaffold | Experimental | Smart Matrix dermal replacement scaffold |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart Matrix scaffold | Device | Smart Matrix dermal replacement scaffold |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of infection and device-related adverse events | Safety | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Complete wound healing | Measurement of time to >95% re-epithelisiation of wound | 24 weeks, 52 weeks |
| Cosmesis | Assessment of scar formation and development using the Patient and Observer Scar Assessment Scale (POSAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Baljit Dheansa, MBBS FRCS | Queen Victoria Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poole General Hospital | Poole | Dorset | BH15 2JB | United Kingdom | ||
| Broomfield Hospital |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 24 weeks, 52 weeks |
| Cosmesis | Assessment of scar formation and development using the Vancouver Scar Scale (VSS) | 24 weeks, 52 weeks |
| Pain at dressing change | Pain at dressing change assessed using a 10 cm VAS | 24 weeks, 52 weeks |
| Dressing change | Number of dressing changes will be recorded | 24 weeks, 52 weeks |
| Chelmsford |
| Essex |
| CM1 7ET |
| United Kingdom |
| Wythenshawe Hospital, Manchester University NHS Foundation Trust | Manchester | Greater Manchester | M23 9LT | United Kingdom |
| The Queen Victoria Hospital NHS Foundation Trust | East Grinstead | West Sussex | RH19 3DZ | United Kingdom |
| D018295 |
| Neoplasms, Basal Cell |
| D018307 | Neoplasms, Squamous Cell |