Clinical trial NCT06760611: Tissue Quality of Integra vs. BTM Treated Burns
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Burn Injury
Burn Scar
Burn Wounds - Partial Thickness (2nd Degree)
Skin Grafting
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2025-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: This study aims to enroll a total of up to 60 subjects, with 25 unique patients in the Integra-treated burns cohort 25 unique patients in the BTM-treated burns cohort, and up to 10 unique patients in the combination arm

Brief 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 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.

Primary outcomes:
measure: Time from Integra or BTM treated burns to autograft procedure
timeFrame: 12-36 months post final skin graft application
measure: Vancouver Scar Scale assessment of tissue quality
timeFrame: 12-36 months post final skin graft application
Secondary outcomes:
measure: Length of Hospital Stays
timeFrame: 12-36 months post final skin graft application
measure: Number of complications
timeFrame: 12-36 months post final skin graft application
measure: Number of re-operations
timeFrame: 12-36 months post final skin graft application
measure: Number of re-admissions
timeFrame: 12-36 months post final skin graft application
measure: Number of days in ICU
timeFrame: 12-36 months post final skin graft application
measure: Percent of Integra or BTM 'take'
timeFrame: 12-36 months post final skin graft application
measure: Time from admission to Integra or BTM application
timeFrame: 12-36 months post final skin graft application
measure: Autograft site details specifically associated with application of Integra or BTM on index injury
timeFrame: 12-36 months post final skin graft application
measure: Patient-Observer Scar Assessment Scale (POSAS)
timeFrame: 12-36 months post final skin graft application
measure: Patient Survey Question regarding neuropathic pain
timeFrame: 12-36 months post final skin graft application
measure: Tissue Pliability / Elasticity
timeFrame: 12-36 months post final skin graft application
measure: Tissue Height
timeFrame: 12-36 months post final skin graft application
measure: Tissue Density
timeFrame: 12-36 months post final skin graft application
measure: Tissue Sensitivity
timeFrame: 12-36 months post final skin graft application
Other outcomes:
Locations:
Study officials:
affiliation: Medical Affairs
name: Yi Arnold
role: STUDY_DIRECTOR
References: