An interventional study of SupraSDRM® and NovoSorb® BTM in Surgical Wound, Burns and Trauma Injury, sponsored by The Metis Foundation. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by The Metis Foundation · Not applicable, Interventional, and Treatment
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.
315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.
This study's planned enrollment of 24 is below the median of 66 across 242 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →The Metis Foundation is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Once randomization is completed and the site is adequately debrided the assigned treatment dressing will be applied according to their respective instructions for use. Supplemental supportive dressings including negative pressure treatment may be used in conjunction with the study dressings.
Device: SupraSDRM®
Once randomization is completed and the site is adequately debrided the assigned treatment dressing will be applied according to their respective instructions for use. Supplemental supportive dressings including negative pressure treatment may be used in conjunction with the study dressings.
Device: NovoSorb® BTM
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Dec 2027, 23 months after the start.
Of 99 non-industry interventional studies with no phase under Surgical Wound, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 53. This study's planned 23 months is close to that.
Counting every sponsor, half of 126 studies reached it within 18 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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The Metis Foundation