NCT06760611

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2025-01-07
• Last updated: 2026-01-07