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Tissue Quality of Integra vs. BTM Treated Burns | Clinical Trials | Clareo Health

WITHDRAWN

Tissue Quality of Integra vs. BTM Treated Burns

An Observational Cohort Analysis of Tissue Quality of Integra Dermal Matrix (Integra®)-Treated Burns and NovoSorb® Biodegradable Temporizing Matrix (BTM)-Treated Burns 12-36 Months Post Final Skin Graft Application

NCT06760611•Integra LifeSciences Corporation

View on ClinicalTrials.gov

Summary

An observational analysis of Integra-treated burns and Novosorb Biodegradable Temporizing Matrix (BTM)-treated burns will be undertaken 12-36 months post final skin graft application by retrospectively analyzing the patient's electronic medical record, and prospectively using a non-invasive measures of tissue quality and patient-reported outcomes. Patients will be offered the option to consent for a tissue biopsy for pathological evaluation.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient has reviewed the IRB-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the IRB-approved consent form.
•2. Patient had a deep dermal or full-thickness burn that required skin grafting that was first treated with Integra\* or BTM, and at least 70% 'take' followed by an autograft
•3. Patient had final skin graft between 12-36 months prior enrollment in the study.
•4. Burn must have been ≥10% total body surface area (TBSA) and ≤70% TBSA.
•5. Patient is ≥ 21 years of age at the time of treatment.

Exclusion Criteria

•1. Patient had a radiation burn.
•2. Patient was treated with Integra or BTM and closed via secondary intention.
•3. Severe cognitive dysfunction or psychiatric disorders.
•4. Immunocompromised patients.

Key Dates

Start Date

March 1, 2025

Primary Completion Date

September 30, 2025

Completion Date

September 30, 2025

Last Updated

January 7, 2026

Conditions

Burn InjuryBurn ScarBurn Wounds - Partial Thickness (2nd Degree)Skin Grafting

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Tissue Quality of Integra vs. BTM Treated Burns

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