WithdrawnNot Applicable

Tissue Quality of Integra vs. BTM Treated Burns

Stopped: change in company prioritizations

0Started 2025-03-01

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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
✓. Patient had final skin graft between 12-36 months prior enrollment in the study.
✓. Burn must have been ≥10% total body surface area (TBSA) and ≤70% TBSA.
✓. Patient is ≥ 21 years of age at the time of treatment.

Exclusion criteria

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

What they're measuring

Time from Integra or BTM treated burns to autograft procedure

Timeframe: 12-36 months post final skin graft application

Vancouver Scar Scale assessment of tissue quality

Timeframe: 12-36 months post final skin graft application

Trial details

NCT IDNCT06760611

SponsorIntegra LifeSciences Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Burn Injury trials