Tissue Quality of Integra vs. BTM Treated Burns

Integra LifeSciences

Status: Begins enrollment in 9 months

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

Study type: Observational

Funder types: Industry

Identifiers

NCT06760611

T-IDRTTQ-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 3 patient groups

Integra Cohort

Description:

Patient with a burn treated with Integra® in conjunction with standard of care (SOC)\* 12-36 months post final skin graft application. 25 unique cases will be enrolled into this group.

BTM Cohort

Description:

Patient with a burn treated with BTM in conjunction with SOC\* 12-36 months post- skin graft application. 25 unique cases will be enrolled into this group.

Combination Cohort

Description:

Patient with a burn treated with Integra and BTM in different regions of the body in conjunction with SOC\* 12-36 months post-skin graft application. Up to 10 unique cases can be enrolled into this group.