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Not yet recruiting NCT06503406

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

No phase Interventional Surgical Wound Burns Trauma Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SupraSDRM®, NovoSorb® BTM.
Who it may be relevant to
Registry conditions: Surgical Wound, Burns, Trauma Injury. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device SupraSDRM®
    SupraSDRM® Bidegradable Matrix Wound Dressing is a tri-polymber, Biodegrable dermal covering manufactured by PolyMedics Innovations, GmbH.
  • Device NovoSorb® BTM
    NovoSorb® BTM absorbable synthetic wound dressing, PolyNovo Biomaterials, K172140

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06503406 · Pro00076270 · CDMRP-RC220169 · E04634.1a

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗