BurnsNCT04090424
Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns
A study testing NovoSorb BTM in people with Burns, run by PolyNovo Biomaterials Pty Ltd. at 26 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Burns
- What is being tested?
- NovoSorb BTM
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 21 Sep 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent directly or via legal representative prior to any clinical study procedures being performed
- Willing to comply with all study procedures and expects to be available for the duration of the study
- Male and females ≥ 18 years of age and ≤ 75 years of age
- 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
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- Flame
- Flash
- Contact
- 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.
- The minimum total area across all lesions to have NovoSorb® BTM applied is 3% TBSA
- Females, who are non-pregnant, naturally postmenopausal, or who agree to use effective contraceptive methods throughout the course of the study.
Who cannot join
- Has a known hypersensitivity to polyurethane
- Only a non-burn injury has been experienced by the subject including soft-tissue degloving and friction burn/crush, i.e., road rash
- Multiple traumas, i.e., significant traumatic injury to a solid organ in addition to skin
- Presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy
- 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
- For females - has known or suspected pregnancy, planned pregnancy, or during lactation
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- Has exposure to any other investigational agent within the last 6 months
- Has exposure to any other treatment/device that will interfere with NovoSorb® BTM integration
- Anticipated inability to perform wound care and follow-up procedures
- Anticipates of a level of non-compliance
- The use of off-label treatments for full-thickness / deep-dermal burns is not permitted
- 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
- The use of NovoSorb® BTM on the face and in the perineum area is not permitted
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States23 sites
Akron Children's Hospital, Burn Center
Akron, Ohio, 44308
Lehigh Valley Hospital and Health Network
Allentown, Pennsylvania, 18103
Emory University at Grady Memorial Hospital
Atlanta, Georgia, 30303
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02446
Bridgeport Hospital
Bridgeport, Connecticut, 06610
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
The Ohio State University/ Wexner Medical Center
Columbus, Ohio, 43210
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
University of Kansas Hospital
Kansas City, Kansas, 66160
Southern California Regional Burn Center at LAC+USC
Los Angeles, California, 90033
UW Health University Hospital
Madison, Wisconsin, 53792
Loyola University of Chicago
Maywood, Illinois, 60153
University Medical Center, New Orleans
New Orleans, Louisiana, 70112
New York Presbyterian Weill Cornell Medicine
New York, New York, 10065
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Valleywise Health
Phoenix, Arizona, 85008
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23219
University of California Davis Medical Center
Sacramento, California, 95817
Tampa General Hospital
Tampa, Florida, 33606
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Wake Forest Baptist Health
Winston-Salem, North Carolina, 24157
India3 sites
Bembde Hospital
Chhatrapati Sambhajinagar, Maharashtra
Ganga Medical Centre and Hospitals PVT Ltd
Coimbatore, Tamil Nadu
National Burns Centre
Mumbai, Maharashtra
About this study
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
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).
Read the 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).
- Conditions
- Burns
- Being tested
- NovoSorb BTM, Standard of Care
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoSorb BTMDevice
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.
Standard of CareProcedure or surgery
Burn wounds will be treated using the institution's standard of care, e.g. primary skin grafting, cadaveric allograft followed by skin grafting.
| Study group | Role | What they receive |
|---|---|---|
| NovoSorb BTM | Experimental | Application of NovoSorb BTM to study lesions Receives: Device: NovoSorb BTM |
| Standard of Care | Active comparator | Application of the institution's standard of care to study lesions. Receives: Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of study lesions in both groups with complete wound closure after skin grafting
Assessment of clinical outcome by wound closure
Measured: 4 weeks after skin grafting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start21 Sep 2021
- Primary completion30 May 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PolyNovo Biomaterials Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Marcus Wagstaff, MBBS, PhD, Study director, Royal Adelaide Hospital, Adelaide SA 5000. Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090424
- Sponsor's protocol ID
- CP-003
- Status last verified
- Feb 2026
- First submitted
- 12 Sep 2019
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04090424
- Acronym / sponsor ID
- CP-003
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- PolyNovo Biomaterials Pty Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NovoSorb BTM | Experimental | Device: NovoSorb BTMApplication of NovoSorb BTM to study lesions |
| Standard of Care | Active comparator | Procedure: Standard of CareApplication of the institution's standard of care to study lesions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provide written informed consent directly or via legal representative prior to any clinical study procedures being performed
- Willing to comply with all study procedures and expects to be available for the duration of the study
- Male and females ≥ 18 years of age and ≤ 75 years of age
- Patients with deep dermal or full thickness burns between 3% and 60%, inclusive, of their total body surface area (TBSA).
- 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.
Key exclusion criteria (13 listed)
- Has a known hypersensitivity to polyurethane
- Only a non-burn injury has been experienced by the subject including soft-tissue degloving and friction burn/crush, i.e., road rash
- Multiple traumas, i.e., significant traumatic injury to a solid organ in addition to skin
- Presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NovoSorb BTMNovoSorb 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. | Device | NovoSorb BTM |
| Standard of CareBurn wounds will be treated using the institution's standard of care, e.g. primary skin grafting, cadaveric allograft followed by skin grafting. | Procedure or surgery | Standard of Care |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Sponsor websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Wagstaff, MBBS, PhD study director
Royal Adelaide Hospital, Adelaide SA 5000. Australia
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NovoSorb BTM in people with Burns, run by PolyNovo Biomaterials Pty Ltd. at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of study lesions in both groups with complete wound closure after skin grafting (time frame: 4 weeks after skin grafting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.