Tissue Quality of Integra vs. BTM Treated Burns

NCT06760611 | Withdrawn

• 1 other identifier: T-IDRTTQ-001
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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).

  12-36 months post final skin graft application

• Vancouver Scar Scale assessment of tissue quality

  Tissue quality will be assessed using the Vancouver Scar Scale (VSS) (to qualitatively measure scar quality) between an overall score of 0-13. A higher score on the VSS represents clinically worse scars.

  12-36 months post final skin graft application

Secondary Outcomes (14)

• Length of Hospital Stays

  12-36 months post final skin graft application

• Number of complications

  12-36 months post final skin graft application

• Number of re-operations

  12-36 months post final skin graft application

• Number of re-admissions

  12-36 months post final skin graft application

• Number of days in ICU

  12-36 months post final skin graft application

Study Arms (3)

Integra Cohort

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

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

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.
• 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
• Patient had final skin graft between 12-36 months prior enrollment in the study.
• Burn must have been ≥10% total body surface area (TBSA) and ≤70% TBSA.
• Patient is ≥ 21 years of age at the time of treatment.

You may not qualify if:

• Patient had a radiation burn.
• Patient was treated with Integra or BTM and closed via secondary intention.
• Severe cognitive dysfunction or psychiatric disorders.
• Immunocompromised patients.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Biospecimen

Retention: SAMPLES WITH DNA

optional skin punch biopsy samples

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Yi Arnold

  Medical Affairs

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: January 7, 2025
• Study Start: March 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share