Tissue Quality of Integra vs. BTM Treated Burns

Launched by INTEGRA LIFESCIENCES CORPORATION · Jan 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well two different treatments for burn injuries—Integra and Novosorb Biodegradable Temporizing Matrix (BTM)—work in terms of tissue quality and patient recovery. Researchers will look at patients' medical records and use non-invasive tests to measure how the skin has healed and how patients feel about their recovery, about one to three years after their final skin graft. Participants will also have the option to provide a small tissue sample for further analysis.

To be eligible for this study, patients must be at least 21 years old and have had a deep burn that required skin grafting, specifically one treated with either Integra or BTM. The burn must cover between 10% and 70% of the body. If you're interested in participating, you'll first review and sign a consent form to confirm your willingness to join the study. It's important to note that individuals with certain conditions, such as radiation burns or severe mental health issues, will not be eligible. This trial is currently not recruiting participants yet.

Gender

ALL

Eligibility criteria

• 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.