Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- Patient age ≥18 years and ≤85 years
- Full-thickness traumatic injury, surgical wound, or excised full-thickness burn (e.g., friction, contact, flame, scalding etiology), where immediate grafting is not deemed suitable by the treating surgeon
- Wound size ≥ 5cm2 not immediately suitable for graft application
- Subject or legally authorized representative is able and willing to sign informed consent
Exclusion Criteria:
- Study wound may not include areas of the face, and neck and genitalia.
- Wound with metal hardware exposure
- Pressure sores
- Wounds with residual malignancy
- Wound infection at the time of planned wound dressing application
- Wound that is a part of an active treatment arm of an interventional study (within 90 days of Screening Visit)
- Pregnancy/lactation
- Subjects who are unable to follow the protocol or who are likely to be non-compliant
- Subjects with uncontrolled diabetes (defined by Hgb A1C \>10)
- Subjects who are receiving systemic steroids or immune suppressive treatment
- Subject with a known allergy to polylactide, polycaprolactone, polyvinyl alcohol, trimethylene carbonate or resorbable suture materials.
- Prisoners
