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

The Metis Foundation

Status: Not yet enrolling

Conditions: Surgical Wound; Trauma Injury; Burns

Treatments: Device: NovoSorb® BTM; Device: SupraSDRM®

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06503406

CDMRP-RC220169 (Other Grant/Funding Number)

E04634.1a (Other Identifier)

Pro00076270

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

SupraSDRM®

Experimental group

Description:

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.

Treatment:

Device: SupraSDRM®

SOC Skin Substitute

Active Comparator group

Description:

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.

Treatment:

Device: NovoSorb® BTM