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Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns

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ClinicalTrials.gov Identifier: NCT04090424
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
PolyNovo Biomaterials Pty Ltd.

Brief Summary:
This is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using NovoSorb Biodegradable Temporizing Matrix (BTM).

Condition or disease Intervention/treatment Phase
Burns Device: NovoSorb BTM Procedure: Standard of Care Not Applicable

Detailed Description:
This is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using NovoSorb Biodegradable Temporizing Matrix (BTM). A comparison will be made between burn wounds treated with BTM and the institution's standard of care (SOC).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pivotal Study to Assess the Safety and Effectiveness of NovoSorb® Biodegradable Temporizing Matrix (BTM) in the Treatment of Severe Burn Skin Injuries
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: NovoSorb BTM
Application of NovoSorb BTM to study lesions
Device: NovoSorb BTM
NovoSorb BTM comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a nonbiodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

Active Comparator: Standard of Care
Application of the institution's standard to care to study lesions.
Procedure: Standard of Care
Burn wounds will be treated using the institution's standard of care, e.g. primary skin grafting, cadaveric allograft followed by skin grafting.




Primary Outcome Measures :
  1. Proportion of study lesions in both groups with complete wound closure after skin grafting [ Time Frame: 4 weeks after skin grafting ]
    Assessment of clinical outcome by wound closure



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide written informed consent directly or via legal representative prior to any clinical study procedures being performed
  2. Willing to comply with all study procedures and expects to be available for the duration of the study
  3. Male and females ≥ 21 years of age and ≤ 70 years of age
  4. Patients with deep dermal or full thickness burns between 5% and 50%, inclusive, of their total body surface area (TBSA).

    Types of burns include the following:

    • Scalding including from hot water, cooking oil, grease
    • Flame
    • Contact
  5. Females, who are non-pregnant, naturally postmenopausal, or who agree to use effective contraceptive methods throughout the course of the study

Exclusion Criteria:

  1. Has a known hypersensitivity to polyurethane
  2. Only a non-burn injury has been experienced by the subject including soft-tissue degloving and friction burn/crush, i.e., road rash
  3. Multiple traumas, i.e., significant traumatic injury to a solid organ in addition to skin
  4. Presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy
  5. Presence of a medical condition that might interfere with treatment evaluation; or require a change in therapy including but not limited to, significant immune deficiency, or skin or vascular diseases in the area of the wound
  6. For females - has known or suspected pregnancy, planned pregnancy, or during lactation
  7. Has exposure to any other investigational agent within the last 6 months
  8. Has exposure to any other treatment/device that will interfere with NovoSorb® BTM integration
  9. Anticipated inability to perform wound care and follow-up procedures
  10. History of non-medical compliance
  11. For NovoSorb BTM subjects, BTM cannot be used on face, neck, hands, and plantar aspect of the foot.
  12. The use of other dermal replacement matrices or off-label treatment for full thickness / deep-dermal burns

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090424


Contacts
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Contact: Timothy Barker, PhD +61386814054 tim.b@polynovo.com
Contact: Heidi Arambula, MPH +16197234331 heidi.a@polynovo.com

Sponsors and Collaborators
PolyNovo Biomaterials Pty Ltd.
Investigators
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Study Director: Marcus Wagstaff, MBBS, PhD Royal Adelaide Hospital, Adelaide SA 5000. Australia

Additional Information:
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Responsible Party: PolyNovo Biomaterials Pty Ltd.
ClinicalTrials.gov Identifier: NCT04090424     History of Changes
Other Study ID Numbers: CP-003
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Burns
Wounds and Injuries