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

Sponsor
PolyNovo Biomaterials Pty Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04090424
Collaborator
Biomedical Advanced Research and Development Authority (U.S. Fed)
150
Enrollment
23
Locations
2
Arms
47.4
Anticipated Duration (Months)
6.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: NovoSorb BTM
  • Procedure: Standard of Care
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
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
Actual Study Start Date :
May 19, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Proportion of study lesions in both groups with complete wound closure after skin grafting [4 weeks after skin grafting]

    Assessment of clinical outcome by wound closure

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • Flash

  • Contact

  1. 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.

  2. The minimum total area across all lesions to have NovoSorb® BTM applied is 5% BSA

  3. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of South Alabama Mobile Alabama United States 36617
2 Valleywise Health Phoenix Arizona United States 85008
3 Southern California Regional Burn Center at LAC+USC Los Angeles California United States 90033
4 University of California Davis Medical Center Sacramento California United States 95817
5 Bridgeport Hospital Bridgeport Connecticut United States 06610
6 MedStar Washington Hospital Center Washington District of Columbia United States 20010
7 University of Florida, Shands Hospital Gainesville Florida United States 32610
8 Tampa General Hospital Tampa Florida United States 33606
9 Eskenazi Health Indianapolis Indiana United States 46202
10 University of Kansas Hospital Kansas City Kansas United States 66160
11 Baton Rouge General Medical Center Baton Rouge Louisiana United States 70809
12 University Medical Center, New Orleans New Orleans Louisiana United States 70112
13 Johns Hopkins Burn Center Baltimore Maryland United States 21224
14 Brigham and Women's Hospital Boston Massachusetts United States 02115
15 Massachusetts General Hospital Boston Massachusetts United States 02446
16 University Of Rochester Medical Center Rochester New York United States 14642
17 Wake Forest Baptist Health Winston-Salem North Carolina United States 24157
18 Akron Children's Hospital, Burn Center Akron Ohio United States 44308
19 The Ohio State University/ Wexner Medical Center Columbus Ohio United States 43210
20 Legacy Emanuel Medical Center, and the Oregon Burn Center Portland Oregon United States 97227
21 Lehigh Valley Hospital and Health Network Allentown Pennsylvania United States 18103
22 University of Utah Health Salt Lake City Utah United States 84132
23 UW Health University Hospital Madison Wisconsin United States 53792

Sponsors and Collaborators

  • PolyNovo Biomaterials Pty Ltd.
  • Biomedical Advanced Research and Development Authority

Investigators

  • Study Director: Marcus Wagstaff, MBBS, PhD, Royal Adelaide Hospital, Adelaide SA 5000. Australia

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
PolyNovo Biomaterials Pty Ltd.
ClinicalTrials.gov Identifier:
NCT04090424
Other Study ID Numbers:
  • CP-003
First Posted:
Sep 16, 2019
Last Update Posted:
May 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Burns

Study Results

No Results Posted as of May 16, 2022