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change in company prioritizations
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stays | Length of hospital stay in days following treatment of burns with Integra or BTM | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Yi Arnold | Medical Affairs | Study Director |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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optional skin punch biopsy samples
| 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 | 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 | 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 | 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 | 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 | 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 | 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/ | 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? | 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. | 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. | 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. | 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. | 12-36 months post final skin graft application |