Tissue Quality of Integra vs. BTM Treated Burns

Integra LifeSciences Corporation

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Burn Injury Burn Scar Burn Wounds - Partial Thickness (2nd Degree)Skin Grafting

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Time from Integra or BTM treated burns to autograft procedure

The primary evaluation of clinical use of Integra- and BTM-treated burns will be undertaken by assessing the time from device application to autograft procedure (time to graft).