NovoSorb BTM for Severe Burns

Recruiting at 35 trial locations

Overseen By Kim Bradbury

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: PolyNovo Biomaterials Pty Ltd.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if your current treatment might interfere with NovoSorb® BTM, it could be a consideration. Please discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment NovoSorb BTM for severe burns?

Research shows that NovoSorb BTM, a synthetic skin substitute, is effective in treating severe burns by helping the skin heal and regenerate. It has been used successfully in various types of wounds, including deep burns, and provides temporary coverage while the patient's own skin heals. ^{1 2 3 4 5}

How is the treatment NovoSorb BTM different from other treatments for severe burns?

NovoSorb BTM is unique because it is a synthetic dermal template that helps create a new layer of skin (neodermis) before covering it with a skin graft. This two-stage process is different from traditional methods that may rely solely on skin grafts, and it is particularly useful when there is not enough donor skin available for immediate grafting. ^{1 2 3 4 5}

Research Team

Marcus Wagstaff, MBBS, PhD

Principal Investigator

Royal Adelaide Hospital, Adelaide SA 5000. Australia

Eligibility Criteria

Adults aged 18-75 with severe burns covering 3%-60% of their body can join this trial. They must be able to give consent, follow the study plan, and not be pregnant or planning pregnancy. People with allergies to polyurethane, multiple traumas, recent other treatments that could affect results, or infections in the burn area cannot participate.

Inclusion Criteria

The minimum total area across all lesions to have NovoSorb® BTM applied is 3% TBSA

My burn is from scalding, flame, flash, or direct contact.

Provide written informed consent directly or via legal representative prior to any clinical study procedures being performed

Exclusion Criteria

Has exposure to any other investigational agent within the last 6 months

I have a health condition that may limit my life to under a year.

I have had serious injuries to an organ and my skin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Application of NovoSorb BTM or standard of care to study lesions

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• NovoSorb BTM

Trial Overview The trial is testing NovoSorb BTM against standard care for treating severe burns. It's a multi-center study where patients will undergo staged surgeries: first to remove burned tissue and later to apply a skin graft over the treated area.

Participant Groups

Group I: NovoSorb BTM Experimental Treatment 1 Intervention

Application of NovoSorb BTM to study lesions

Group II: Standard of Care Active Control 1 Intervention

Application of the institution's standard of care to study lesions.

Who Is Running the Clinical Trial?

PolyNovo Biomaterials Pty Ltd.

Lead Sponsor

Trials

4

Recruited

200+

Biomedical Advanced Research and Development Authority

Collaborator

Trials

108

Recruited

574,000+

Findings from Research

NovoSorb Biodegradable Temporising Matrix (BTM) is an effective reconstructive option for various complex skin defects, including those from burns and infections, as it allows for a two-stage reconstruction process that can lead to successful skin grafting.

Despite complications like infection and non-adherence, BTM showed a good tolerance to these issues, often allowing the reconstruction process to continue as planned after vascularization, which is indicated by a red-pink color and capillary refill.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A consecutive case series of defects reconstructed using NovoSorbⓇ Biodegradable Temporising Matrix: Initial experience and early results. Solanki, NS., York, B., Gao, Y., et al.[2020]

In a multicenter study involving 30 patients with deep burn injuries, the synthetic polyurethane dermal template (NovoSorb® BTM) demonstrated a high mean split skin graft take of 81.9% and a BTM take of 88.6%, indicating effective integration and performance as a dermal substitute.

The study also showed that BTM could integrate successfully even in the presence of infection signs, and scar quality improved over time, highlighting its safety and potential benefits in burn treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound healing and dermal regeneration in severe burn patients treated with NovoSorb® Biodegradable Temporising Matrix: A prospective clinical study. Lo, CH., Brown, JN., Dantzer, EJG., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A consecutive case series of defects reconstructed using NovoSorbⓇ Biodegradable Temporising Matrix: Initial experience and early results. [2020]

2. England pubmed.ncbi.nlm.nih.gov

The use of NovoSorb biodegradable temporising matrix in wound management: a literature review and case series. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Wound healing and dermal regeneration in severe burn patients treated with NovoSorb® Biodegradable Temporising Matrix: A prospective clinical study. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Experience with NovoSorb® Biodegradable Temporising Matrix in reconstruction of complex wounds. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical outcomes and resource utilisation in patients with major burns treated with NovoSorb® BTM. [2023]