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Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds

Primary Purpose

Wound of Skin, Burns

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Suprathel®
Sponsored by
The Metis Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound of Skin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or Female ≥18 years and ≤75 years
  • Acute partial thickness burns by friction, contact, scalding from hot liquids and flame
  • TBSA total ≥2 %; burn treatment region of interest: all areas with partial-thickness burns excluding face, neck, scalp, and feet
  • TBSA 3rd ≤5 % (not to be included as burn treatment region of interest)
  • Subject is able and willing to sign Informed Consent or via legally authorized representative

Exclusion Criteria:

  • Study Wound due to electrical, radioactive, or frostbite-related injury
  • Infection of wounds in the study area at admission per Investigator or treating physician discretion
  • Pregnancy/lactation
  • Subjects who are unable to follow the protocol or who are likely to be non-compliant
  • Participation in an active treatment arm of a burn wound related interventional study within 90 days of Screening Visit or during the study
  • Prisoners
  • Life expectancy less than 6 months
  • Subjects who are receiving steroids, chronic anticoagulants, or immune suppressive treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Suprathel® dressing

    Standard of Care

    Arm Description

    The Suprathel® dressing will be applied to the wound site after standard of care cleaning and debridement. The dressing will be maintained according to the manufacturer's instructions for use

    The Standard of care as prescribed will be followed for the dressing application for the wound site. Dressings will be applied to the wound site after standard of care cleaning and debridement.

    Outcomes

    Primary Outcome Measures

    Need for autograft application
    The reduction of need for grafting measured by the percentage of subjects who are converting to grafting at 21 ± 3 days after application.

    Secondary Outcome Measures

    Wound infection rate, wound closure of the region
    Incidence of infections and inflammatory response and scar development
    Mid and long term clinical scar maturation assessed by the Patient and Observer Scar Assessment Scale (POSAS).
    Patient and Observer Scar Assessment Scale (POSAS) Questionnaire is used to assess scarring.
    Patient-reported perception of pain based on the Visual Analog Scale
    Patients will be asked to rate their pain 0-10 (0=no pain and 10=a lot of pain) prior to and after application of the first dressing and subsequent dressings.

    Full Information

    First Posted
    July 14, 2022
    Last Updated
    October 12, 2022
    Sponsor
    The Metis Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05462860
    Brief Title
    Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
    Official Title
    Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 15, 2023 (Anticipated)
    Primary Completion Date
    September 29, 2024 (Anticipated)
    Study Completion Date
    September 29, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Metis Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the effect to which Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany) can reduce the need for grafting compared to Standard of Care (SoC). Furthermore, the study intends to evaluate if Suprathel® allows for a reduction of reduction of pain, infection, provider workload, scar development and costs compared to SoC.
    Detailed Description
    We are advocating the study of Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany), a synthetic wound dressing made of polymers of D-,L- lactate, and ε caprolactone, in the early coverage of burns for use in Large Scale Combat Operations (LSCOs) as compared to standard of care. The rationale for studying Suprathel® is its favorable physical characteristics as a portable treatment, ease of application by personnel without formal medical training, proven efficacy in improving outcomes after partial-thickness burn injury to include better pain control, preliminary evidence in decreasing burn wound conversion, and the lack of adverse consequences in covering indeterminant depth or full thickness burns.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wound of Skin, Burns

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Proof of concept
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    21 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Suprathel® dressing
    Arm Type
    Experimental
    Arm Description
    The Suprathel® dressing will be applied to the wound site after standard of care cleaning and debridement. The dressing will be maintained according to the manufacturer's instructions for use
    Arm Title
    Standard of Care
    Arm Type
    Active Comparator
    Arm Description
    The Standard of care as prescribed will be followed for the dressing application for the wound site. Dressings will be applied to the wound site after standard of care cleaning and debridement.
    Intervention Type
    Other
    Intervention Name(s)
    Suprathel®
    Other Intervention Name(s)
    standard of care
    Intervention Description
    Application of standard of care dressing.®
    Primary Outcome Measure Information:
    Title
    Need for autograft application
    Description
    The reduction of need for grafting measured by the percentage of subjects who are converting to grafting at 21 ± 3 days after application.
    Time Frame
    21 days
    Secondary Outcome Measure Information:
    Title
    Wound infection rate, wound closure of the region
    Description
    Incidence of infections and inflammatory response and scar development
    Time Frame
    2 weeks, 3 weeks, and 6 weeks after application (without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart)
    Title
    Mid and long term clinical scar maturation assessed by the Patient and Observer Scar Assessment Scale (POSAS).
    Description
    Patient and Observer Scar Assessment Scale (POSAS) Questionnaire is used to assess scarring.
    Time Frame
    Mid (3-9 months) and long term (52 weeks)
    Title
    Patient-reported perception of pain based on the Visual Analog Scale
    Description
    Patients will be asked to rate their pain 0-10 (0=no pain and 10=a lot of pain) prior to and after application of the first dressing and subsequent dressings.
    Time Frame
    After initial application (Day 0) and weekly

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or Female ≥18 years and ≤75 years Acute partial thickness burns by friction, contact, scalding from hot liquids and flame TBSA total ≥2 %; burn treatment region of interest: all areas with partial-thickness burns excluding face, neck, scalp, and feet TBSA 3rd ≤5 % (not to be included as burn treatment region of interest) Subject is able and willing to sign Informed Consent or via legally authorized representative Exclusion Criteria: Study Wound due to electrical, radioactive, or frostbite-related injury Infection of wounds in the study area at admission per Investigator or treating physician discretion Pregnancy/lactation Subjects who are unable to follow the protocol or who are likely to be non-compliant Participation in an active treatment arm of a burn wound related interventional study within 90 days of Screening Visit or during the study Prisoners Life expectancy less than 6 months Subjects who are receiving steroids, chronic anticoagulants, or immune suppressive treatment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Victoria Diaz, RN
    Phone
    2105691140
    Email
    Diaz@metisfoundationusa.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kristin Anselmo
    Email
    Anselmo@metisfoundationusa.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds

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