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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 : Recruiting
First Posted : September 16, 2019
Last Update Posted : January 9, 2023
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
PolyNovo Biomaterials Pty Ltd.

Tracking Information
First Submitted Date  ICMJE September 12, 2019
First Posted Date  ICMJE September 16, 2019
Last Update Posted Date January 9, 2023
Actual Study Start Date  ICMJE May 19, 2021
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2019)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2019)		 Proportion of study lesions in both groups with complete wound closure after skin grafting [ Time Frame: 4 weeks after skin grafting ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns
Official Title  ICMJE A Pivotal Study to Assess the Safety and Effectiveness of NovoSorb® Biodegradable Temporizing Matrix (BTM) in the Treatment of Severe Burn Skin Injuries
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).
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Burns
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: NovoSorb BTM
    Application of NovoSorb BTM to study lesions
    Intervention: Device: NovoSorb BTM
  • Active Comparator: Standard of Care
    Application of the institution's standard to care to study lesions.
    Intervention: Procedure: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 15, 2020)		 150
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2019)		 50
Estimated Study Completion Date  ICMJE May 2025
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ≥ 18 years of age and ≤ 75 years of age

  4. Patients with deep dermal or full thickness burns between 3% and 60%, inclusive, of their total body surface area (TBSA).

    Types of burns include the following:

    • Scalding including from hot water, cooking oil, grease
    • Flame
    • Flash
    • Contact
  5. Subjects who have staged surgical procedures planned e.g., one procedure to excise the burn injury and a later procedure to prepare the wound bed and apply an autologous skin graft.
  6. The minimum total area across all lesions to have NovoSorb® BTM applied is 3% BSA
  7. 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. Anticipates of a level of non-compliance
  11. The use of off-label treatments for full-thickness / deep-dermal burns is not permitted
  12. Clinical signs of wound infection at areas to be potentially treated using NovoSorb® BTM that in the opinion of the investigator may compromise safety and study objectives
  13. The use of NovoSorb® BTM on the face and in the perineum area is not permitted
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kim Bradbury +1(949) 542-0950 kim.b@polynovo.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04090424
Other Study ID Numbers  ICMJE CP-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party PolyNovo Biomaterials Pty Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE PolyNovo Biomaterials Pty Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Biomedical Advanced Research and Development Authority
Investigators  ICMJE
Study Director: Marcus Wagstaff, MBBS, PhD Royal Adelaide Hospital, Adelaide SA 5000. Australia
PRS Account PolyNovo Biomaterials Pty Ltd.
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP