An observational study in Burn Injury, Burn Scar and Burn Wounds - Partial Thickness (2nd Degree), sponsored by Integra LifeSciences Corporation. Withdrawn. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Integra LifeSciences Corporation · Observational
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.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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).
Time frame: 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.
Time frame: 12-36 months post final skin graft application
Length of Hospital Stays
Length of hospital stay in days following treatment of burns with Integra or BTM
Time frame: 12-36 months post final skin graft application
Number of complications
Number complications (i.e. infection) in burns treated with Integra vs burns treated with BTM
Time frame: 12-36 months post final skin graft application
Number of re-operations
Number of re-operations in burns treated with Integra vs burns treated with BTM
Time frame: 12-36 months post final skin graft application
Number of re-admissions
Number of re-admissions in burns treated with Integra vs burns treated with BTM
Time frame: 12-36 months post final skin graft application
Number of days in ICU
Number of days in ICU of patients with burns treated with Integra vs burns treated with BTM
Time frame: 12-36 months post final skin graft application
Percent of Integra or BTM 'take'
Percent of Integra or BTM 'take' in burns treated with Integra vs burns treated with BTM
Time frame: 12-36 months post final skin graft application
Time from admission to Integra or BTM application
Time (number of days) from admission to Integra or BTM application to the burn
Time frame: 12-36 months post final skin graft application
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
Time frame: 12-36 months post final skin graft application
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/
Time frame: 12-36 months post final skin graft application
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?
Time frame: 12-36 months post final skin graft application
Tissue Pliability / Elasticity
Use of a cutometer to measure tissue pliability / elasticity in burns treated with Integra vs burns treated with BTM.
Time frame: 12-36 months post final skin graft application
Tissue Height
Use of an ultrasound to measure tissue height in burns treated with Integra vs burns treated with BTM.
Time frame: 12-36 months post final skin graft application
Tissue Density
Use of an ultrasound to measure tissue density in burns treated with Integra vs burns treated with BTM.
Time frame: 12-36 months post final skin graft application
Tissue Sensitivity
Use of the Semmes-Weinstein Aesthesiometer to measure tissue sensitivity in burns treated with Integra vs burns treated with BTM.
Time frame: 12-36 months post final skin graft application
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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