A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds

Launched by THE METIS FOUNDATION · Jul 9, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called SupraSDRM® to help heal full-thickness wounds, such as surgical wounds, burns, or injuries, that cannot be immediately covered with a skin graft. The researchers want to see if this new treatment works better than the standard wound dressing currently used. The study will involve patients from various centers and will compare the healing times and outcomes between the two methods.

To participate in this trial, individuals must be between 18 and 85 years old and have a full-thickness wound that is at least 5 cm² in size, where immediate grafting is not suitable. However, there are some exclusions, such as individuals with wounds on the face or neck, certain medical conditions, or those who cannot follow the study requirements. Participants will be asked to sign a consent form and can expect regular follow-ups to monitor their healing progress. This trial is currently not recruiting participants, but it aims to provide valuable insights into better wound care in the future.

Gender

ALL

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