NovoSorb BTM for Severe Burns

Recruiting in Palo Alto (17 mi)

+35 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: PolyNovo Biomaterials Pty Ltd.

No Placebo Group

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).

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

I am between 18 and 75 years old.

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

+9 more

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.

+10 more

Participant Groups

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.

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.