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Burn InjuryNCT06760611

Tissue Quality of Integra vs. BTM Treated Burns

An observational study of Burn Injury and Burn Scar, run by Integra LifeSciences Corporation.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 21 years and older
How many people
0 participants
Where
No sites listed yet
Study dates
1 Mar 2025to 30 Sep 2025
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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

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.

Medical subject headings
Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06760611
Study groupRoleWhat they receive
Integra CohortPatient 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 CohortPatient 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 CohortPatient 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 12-36 months post final skin graft application

  2. 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.

    Measured: 12-36 months post final skin graft application

Secondary outcomes (14)

  1. Length of Hospital Stays

    Length of hospital stay in days following treatment of burns with Integra or BTM

    Measured: 12-36 months post final skin graft application

  2. Number of complications

    Number complications (i.e. infection) in burns treated with Integra vs burns treated with BTM

    Measured: 12-36 months post final skin graft application

  3. Number of re-operations

    Number of re-operations in burns treated with Integra vs burns treated with BTM

    Measured: 12-36 months post final skin graft application

  4. Number of re-admissions

    Number of re-admissions in burns treated with Integra vs burns treated with BTM

    Measured: 12-36 months post final skin graft application

  5. Number of days in ICU

    Number of days in ICU of patients with burns treated with Integra vs burns treated with BTM

    Measured: 12-36 months post final skin graft application

  6. Percent of Integra or BTM 'take'

    Percent of Integra or BTM 'take' in burns treated with Integra vs burns treated with BTM

    Measured: 12-36 months post final skin graft application

  7. Time from admission to Integra or BTM application

    Time (number of days) from admission to Integra or BTM application to the burn

    Measured: 12-36 months post final skin graft application

  8. Autograft site details specifically associated with application of Integra or BTM on index injury

    Size, thickness, and mesh of autograft site specifically associated with application of Integra or BTM on index injury

    Measured: 12-36 months post final skin graft application

  9. Patient-Observer Scar Assessment Scale (POSAS)

    Qualitative evaluation of burns treated with Integra vs burns treated with BTM utilizing the POSAS.

    The POSAS total score ranges from 6 to 60. The lower score corresponds to a situation of normal skin and as scores increase, it corresponds to a situation different from normal skin/

    Measured: 12-36 months post final skin graft application

  10. Patient Survey Question regarding neuropathic pain

    Patient survey question regarding neuropathic pain in burns treated with Integra vs burns treated with BTM.

    Patient Survey Question: Do you experience neuropathic pain (numbness, pins and needles (tingling), or burning sensation) in your burn scar?

    Measured: 12-36 months post final skin graft application

  11. Tissue Pliability / Elasticity

    Use of a cutometer to measure tissue pliability / elasticity in burns treated with Integra vs burns treated with BTM.

    Measured: 12-36 months post final skin graft application

  12. Tissue Height

    Use of an ultrasound to measure tissue height in burns treated with Integra vs burns treated with BTM.

    Measured: 12-36 months post final skin graft application

  13. Tissue Density

    Use of an ultrasound to measure tissue density in burns treated with Integra vs burns treated with BTM.

    Measured: 12-36 months post final skin graft application

  14. Tissue Sensitivity

    Use of the Semmes-Weinstein Aesthesiometer to measure tissue sensitivity in burns treated with Integra vs burns treated with BTM.

    Measured: 12-36 months post final skin graft application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2025
  2. Study start1 Mar 2025 (estimated)
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Why it stopped: change in company prioritizations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06760611
Sponsor's protocol ID
T-IDRTTQ-001
Status last verified
Sep 2026
First submitted
19 Nov 2024
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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