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NCT Number: NCT06760611

Tissue Quality of Integra vs. BTM Treated Burns

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.

Why the study stopped: change in company prioritizations
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Key information

Conditions

Burn Injury Burn Scar Burn Wounds - Partial Thickness (2nd Degree) Burns Skin Grafting Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Time from Integra or BTM treated burns to autograft procedure

    Time frame: 12-36 months post final skin graft application

    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).

  2. Vancouver Scar Scale assessment of tissue quality

    Time frame: 12-36 months post final skin graft application

    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.

Secondary outcomes

  1. Length of Hospital Stays

    Time frame: 12-36 months post final skin graft application

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

  2. Number of complications

    Time frame: 12-36 months post final skin graft application

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

  3. Number of re-operations

    Time frame: 12-36 months post final skin graft application

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

  4. Number of re-admissions

    Time frame: 12-36 months post final skin graft application

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

  5. Number of days in ICU

    Time frame: 12-36 months post final skin graft application

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

  6. Percent of Integra or BTM 'take'

    Time frame: 12-36 months post final skin graft application

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

  7. Time from admission to Integra or BTM application

    Time frame: 12-36 months post final skin graft application

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

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

    Time frame: 12-36 months post final skin graft application

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

  9. Patient-Observer Scar Assessment Scale (POSAS)

    Time frame: 12-36 months post final skin graft application

    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/

  10. Patient Survey Question regarding neuropathic pain

    Time frame: 12-36 months post final skin graft application

    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?

  11. Tissue Pliability / Elasticity

    Time frame: 12-36 months post final skin graft application

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

  12. Tissue Height

    Time frame: 12-36 months post final skin graft application

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

  13. Tissue Density

    Time frame: 12-36 months post final skin graft application

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

  14. Tissue Sensitivity

    Time frame: 12-36 months post final skin graft application

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

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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