NovoSorb BTM for Severe Burns

Not currently recruiting at 36 trial locations

Overseen By Kim Bradbury

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: PolyNovo Biomaterials Pty Ltd.

Disqualifiers: Hypersensitivity to polyurethane, Multiple traumas, Advanced malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NovoSorb BTM for individuals with severe burns. NovoSorb BTM is a special material that temporarily covers wounds to help heal deep skin burns. The study compares NovoSorb BTM to the standard treatment hospitals provide for burns. Suitable candidates for this trial are those who have suffered significant burns from sources like hot water or flames, covering 3% to 60% of their body.

As an unphased trial, this study allows patients to contribute to innovative burn treatment research.

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 prior data suggests that this method is safe for treating severe burns?

Research has shown that NovoSorb BTM is generally safe for treating severe burns. Studies have found it effective in healing complex wounds with a low risk of infection. Reports of unwanted effects with NovoSorb BTM are few. In some cases, infections occurred in both areas treated with BTM and those not treated with it, a common issue in patients with severe burns. Overall, NovoSorb BTM appears well-tolerated by people with burn injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

NovoSorb BTM is unique because it offers a new approach to treating severe burns by using a biodegradable synthetic matrix. Unlike traditional burn treatments that often rely on skin grafts or temporary dressings, NovoSorb BTM provides a scaffold that integrates with the body's tissue, promoting natural skin regeneration. This innovative mechanism can potentially reduce the need for multiple surgeries and improve healing outcomes. Researchers are excited about NovoSorb BTM because it may offer faster recovery and better long-term results compared to standard care options.

What evidence suggests that NovoSorb BTM is effective for severe burns?

Research has shown that NovoSorb BTM, which participants in this trial may receive, effectively treats complex wounds, such as severe burns, with a low risk of infection. One study found that patients with severe burns who used NovoSorb BTM healed well without significant skin tightening. Another study discovered that these patients spent less time in surgery, although they required about the same number of operations as those receiving other treatments. Few side effects have been reported with NovoSorb BTM. These findings suggest that NovoSorb BTM could be a promising option for treating severe burns. ^{1 2 4 6 7}

Who Is on the Research Team?

Marcus Wagstaff, MBBS, PhD

Principal Investigator

Royal Adelaide Hospital, Adelaide SA 5000. Australia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S246891222400066X

A systematic review of the Novosorb® Biodegradable ...

NovoSorb® BTM is effective in treating complex wounds with low infection rates. Minimal adverse events were reported with NovoSorb® BTM use.

2.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT04090424

Study Details | NCT04090424 | Assessment of Safety and ...

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 ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11615573/

Novosorb® BTM- history, production and application in ...

Both patients survived their near total body burns and on follow up presented with stable wound reconstruction without major contraction. 2.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0305417923001018

Clinical outcomes and resource utilisation in patients with ...

Patients treated with BTM had significantly less total operative time and no difference in number of operations, allograft use and ICU LOS.

5.

withpower.com

withpower.com/trial/phase-burns-4-2021-592cf

NovoSorb BTM for Severe Burns · Info for Participants

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 ...

6.

polynovo.com

polynovo.com/wp-content/uploads/sites/4/2020/04/CE-Mark-Trial.pdf

Results of NovoSorb® BTM CE Mark Burn Trial

As may be expected in patients with severe burns, there were infections at both BTM and non-BTM treated wounds, being reported for 10 patients ...

7.

surgery.wisc.edu

surgery.wisc.edu/research/researchers-labs/dr-gibsons-lab/clinical-trials/

Clinical Trials

This is a multicenter, randomized, adaptive design study to compare the safety and effectiveness of NovoSorb® BTM to the standard-of-care in patients with ...