Surgical WoundNCT06503406
A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds
A study testing SupraSDRM® and NovoSorb® BTM in people with Surgical Wound and Burns, run by The Metis Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Surgical Wound, Burns, Trauma Injury
- What is being tested?
- SupraSDRM® and NovoSorb® BTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The United States Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234
Kristin Anselmo, 210-539-9689, kristin.k.anselmo.ctr@health.mil
Alicia Williams
About this study
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.
Read the 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.
- Conditions
- Surgical Wound, Burns, Trauma Injury
- Being tested
- SupraSDRM®, NovoSorb® BTM
- Medical subject headings
- Surgical Wound, Burns, Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupraSDRM®Device
SupraSDRM® Bidegradable Matrix Wound Dressing is a tri-polymber, Biodegrable dermal covering manufactured by PolyMedics Innovations, GmbH.
NovoSorb® BTMDevice
NovoSorb® BTM absorbable synthetic wound dressing, PolyNovo Biomaterials, K172140
| Study group | Role | What they receive |
|---|---|---|
| SupraSDRM® | Experimental | 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. Receives: Device: SupraSDRM® |
| SOC Skin Substitute | Active comparator | 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. Receives: Device: NovoSorb® BTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 5 weeks
Secondary outcomes (7)
Clinical incidence of skin substitute infection
Incidence of infections and inflammatory response and scar development
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start8 Jan 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Metis Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Medical Branch, Galveston, United States Department of Defense, United States Army Institute of Surgical Research
- Responsible party
- Sponsor
- Investigators
- Rodney Chan, MD, Principal investigator, Metis Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503406
- Sponsor's protocol ID
- Pro00076270
- Other IDs
- CDMRP-RC220169, E04634.1a
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds
- ClinicalTrials.gov ID
- NCT06503406
- Acronym / sponsor ID
- Pro00076270
- Conditions
- Surgical Wound, Burns, Trauma Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The Metis FoundationUniversity, hospital or other
- Collaborators
- The University of Texas Medical Branch, Galveston, United States Department of Defense, United States Army Institute of Surgical Research
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SupraSDRM® | Experimental | 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. |
| SOC Skin Substitute | Active comparator | Device: NovoSorb® BTMOnce 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SupraSDRM®SupraSDRM® Bidegradable Matrix Wound Dressing is a tri-polymber, Biodegrable dermal covering manufactured by PolyMedics Innovations, GmbH. | Device | SupraSDRM® |
| NovoSorb® BTMNovoSorb® BTM absorbable synthetic wound dressing, PolyNovo Biomaterials, K172140 | Device | SOC Skin Substitute |
Primary outcome
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.
Time frame: 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.
7 secondary outcomes
Clinical incidence of skin substitute infection
Time frame: up to 5 weeks
Days of skin graft application from time of SupraSDRM® or SoC application
Time frame: up to 5 weeks
Percentage graft survival as assessed 7 days after skin graft application
Time frame: 7 days
Number of return trips to the OR
Time frame: up to 1 year
Skin graft contraction
Time frame: up to 1 year
Wound Pain scale 1-10
Time frame: up to 1 year
Cost-effectiveness
Time frame: up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rodney Chan, MD principal investigator
Metis Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SupraSDRM® and NovoSorb® BTM in people with Surgical Wound and Burns, run by The Metis Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria Diaz, RN (2105691140, Diaz@metisfoundationusa.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: up to 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.