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Biodegradable Temporizing Matrix

NovoSorb BTM for Severe Burns

N/A
Recruiting
Research Sponsored by PolyNovo Biomaterials Pty Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and females ≥ 18 years of age and ≤ 75 years of age
Types of burns include scalding (including from hot water, cooking oil, grease), flame, flash, and contact
Must not have
Presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy
Multiple traumas, i.e., significant traumatic injury to a solid organ in addition to skin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after skin grafting
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new way to treat severe burns using NovoSorb Biodegradable Temporizing Matrix. The safety and effectiveness of this new method will be assessed in this study.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include reactions at the application site due to sensitivity to materials in NovoSorb BTM or complications related to wound healing and infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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My burn is from scalding, flame, flash, or direct contact.
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My wounds cover at least 3% of my body.
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My burn is from scalding, flame, flash, or direct contact.
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I am scheduled for surgeries to treat a burn, including skin grafting.
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My burns cover 3% to 60% of my body.
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I have deep or full thickness burns covering 3% to 60% of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a health condition that may limit my life to under a year.
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I have had serious injuries to an organ and my skin.
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I am not pregnant, planning to become pregnant, or breastfeeding.
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I have not used off-label treatments for severe burns.
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I haven't used treatments that could affect NovoSorb® BTM's effectiveness.
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I have only had non-burn injuries like road rash.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after skin grafting
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after skin grafting for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of study lesions in both groups with complete wound closure after skin grafting

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NovoSorb BTMExperimental Treatment1 Intervention
Application of NovoSorb BTM to study lesions
Group II: Standard of CareActive Control1 Intervention
Application of the institution's standard of care to study lesions.

Find a Location

Who is running the clinical trial?

PolyNovo Biomaterials Pty Ltd.Lead Sponsor
3 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Burns
15 Patients Enrolled for Burns
Biomedical Advanced Research and Development AuthorityFED
94 Previous Clinical Trials
554,009 Total Patients Enrolled
3 Trials studying Burns
35 Patients Enrolled for Burns
Marcus Wagstaff, MBBS, PhDStudy DirectorRoyal Adelaide Hospital, Adelaide SA 5000. Australia

Media Library

NovoSorb BTM (Biodegradable Temporizing Matrix) Clinical Trial Eligibility Overview. Trial Name: NCT04090424 — N/A
Burns Research Study Groups: NovoSorb BTM, Standard of Care
Burns Clinical Trial 2023: NovoSorb BTM Highlights & Side Effects. Trial Name: NCT04090424 — N/A
NovoSorb BTM (Biodegradable Temporizing Matrix) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04090424 — N/A
~7 spots leftby Mar 2025
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