NCT06503406 A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds
| NCT ID | NCT06503406 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Metis Foundation |
| Condition | Surgical Wound |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-01-08 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2026-01-08 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Rodney Chan, MD
PRINCIPAL INVESTIGATOR
Metis Foundation
Frequently Asked Questions
Who can join the NCT06503406 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Surgical Wound. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06503406 currently recruiting?
Yes, NCT06503406 is actively recruiting participants. Contact the research team at Diaz@metisfoundationusa.org for enrollment information.
Where is the NCT06503406 trial being conducted?
This trial is being conducted at Fort Sam Houston, United States.
Who is sponsoring the NCT06503406 clinical trial?
NCT06503406 is sponsored by The Metis Foundation. The principal investigator is Rodney Chan, MD at Metis Foundation. The trial plans to enroll 24 participants.