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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Smart Matrix dermal replacement scaffold
Poole General Hospital
Poole, Dorset, United Kingdom
Broomfield Hospital
Chelmsford, Essex, United Kingdom
Wythenshawe Hospital, Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
The Queen Victoria Hospital NHS Foundation Trust
East Grinstead, West Sussex, United Kingdom
Incidence of infection and device-related adverse events
Safety
Time frame: 24 weeks
Complete wound healing
Measurement of time to \>95% re-epithelisiation of wound
Time frame: 24 weeks, 52 weeks
Cosmesis
Assessment of scar formation and development using the Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 24 weeks, 52 weeks
Cosmesis
Assessment of scar formation and development using the Vancouver Scar Scale (VSS)
Time frame: 24 weeks, 52 weeks
Pain at dressing change
Pain at dressing change assessed using a 10 cm VAS
Time frame: 24 weeks, 52 weeks
Dressing change
Number of dressing changes will be recorded
Time frame: 24 weeks, 52 weeks
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