Burns, Surgical Wound, Trauma Injury
Conditions
Brief summary
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.
Detailed 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.
Interventions
DEVICESupraSDRM®
SupraSDRM® Bidegradable Matrix Wound Dressing is a tri-polymber, Biodegrable dermal covering manufactured by PolyMedics Innovations, GmbH.
DEVICENovoSorb® BTM
NovoSorb® BTM absorbable synthetic wound dressing, PolyNovo Biomaterials, K172140
Sponsors
The Metis Foundation
The University of Texas Medical Branch, Galveston
United States Department of Defense
United States Army Institute of Surgical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | up to 5 weeks | This endpoint is based on the ability of the dermal substitute to rapidly vascularize and allow for placement of a skin graft. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical incidence of skin substitute infection | up to 5 weeks | Incidence of infections and inflammatory response and scar development |
| Days of skin graft application from time of SupraSDRM® or SoC application | up to 5 weeks | The wounds will be assessed for their readiness for grafting by their treating surgeon at minimum weekly |
| Percentage graft survival as assessed 7 days after skin graft application | 7 days | Percent of graft survival will be measured by clinical assessment |
| Number of return trips to the OR | up to 1 year | 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. |
| Skin graft contraction | up to 1 year | 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. |
| Wound Pain scale 1-10 | up to 1 year | Patients will be asked to rate their pain 0-10 (0=no pain and 10=a lot of pain) at each visit |
| Cost-effectiveness | up to 1 year | 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 |
Countries
United States
Contacts
CONTACTVictoria Diaz, RN
PRINCIPAL_INVESTIGATORRodney Chan, MD
Metis Foundation
Outcome results
None listed