This is a prospective, randomized, controlled, multi-center clinical study comparing SupraSDRM® to standard of care wound dressing, BTM, in the treatment of full-thickness wounds deemed not immediately suitable for definitive grafting will be performed.
Twenty-four patients with full-thickness wounds fulfilling inclusion criteria of the study will be consented and enrolled into the clinical trial. An area (≥ 5 and ≤125 cm2) deemed not immediately ready to accept skin graft will be designated as the study site. The study site will be randomized to receive either SupraSDRM® or the SoC wound dressing, NovoSorb® BTM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
SupraSDRM® Bidegradable Matrix Wound Dressing is a tri-polymber, Biodegrable dermal covering manufactured by PolyMedics Innovations, GmbH.
NovoSorb® BTM absorbable synthetic wound dressing, PolyNovo Biomaterials, K172140
Number of days between the application of the dermal substitute to when the dermal substitute is deemed suitable for grafting by the treatment care team.
This endpoint is based on the ability of the dermal substitute to rapidly vascularize and allow for placement of a skin graft.
Time frame: up to 5 weeks
Clinical incidence of skin substitute infection
Incidence of infections and inflammatory response and scar development
Time frame: up to 5 weeks
Days of skin graft application from time of SupraSDRM® or SoC application
The wounds will be assessed for their readiness for grafting by their treating surgeon at minimum weekly
Time frame: up to 5 weeks
Percentage graft survival as assessed 7 days after skin graft application
Percent of graft survival will be measured by clinical assessment
Time frame: 7 days
Number of return trips to the OR
The wounds will be assessed by their care team as part of standard care procedures. Research personal will document any areas of concern or additional surgeries required.
Time frame: up to 1 year
Skin graft contraction
Patient and Observer Scar Assessment Scale (POSAS) Questionnaire will be used to assess scaring and contraction. This scale uses a 1-10 rating scale with 1 being normal and 10 being worst imaginable outcome.
Time frame: up to 1 year
Wound Pain scale 1-10
Patients will be asked to rate their pain 0-10 (0=no pain and 10=a lot of pain) at each visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 1 year
Cost-effectiveness
looking at the overall length of stay in the hospital, the number of trips to the operating room and cost of skin substitute will help determine if the study dressing is more or less cost affective
Time frame: up to 1 year