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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after skin grafting
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
82 Previous Clinical Trials
909,607 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently recruited for this research?

"Confirmed. According to clinicaltrials.gov, the medical trial initiated on May 19th 2021 is currently looking for volunteers. 150 individuals are required between 25 distinct sites in order to complete this project successfully."

Answered by AI

What is the current enrollment status for this experimental trial?

"Affirmative, clinicaltrials.gov has the latest information on this medical trial which was launched in May 2021 and last modified in September 2022- seeking 150 individuals from 25 separate sites."

Answered by AI

Who would be qualified to join this investigation?

"To be eligible to participate, individuals must have suffered from burns and range between 21 and 70 years old. This clinical trial is looking for a total of 150 volunteers."

Answered by AI

Does the current protocol for this medical study include participants over 80 years of age?

"This research requires that participants are within the age range of 21 to 70 years old. The study also has 19 sub-trials for minors and 58 supplementary trials for those over 65."

Answered by AI

In what geographical sites is this research conducted?

"A total of 25 clinical sites are recruiting for this study, among which University of Utah Health in Salt Lake City, Bridgeport Hospital in Bridgeport, and University of Florida Shands Hospital in Gainesville stand out."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns
2021. "Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04090424.
~37 spots leftby Mar 2025
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