Burn Injury, Burn Scar, Burn Wounds - Partial Thickness (2nd Degree), Skin Grafting
Conditions
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.
Interventions
None listed
Sponsors
Integra LifeSciences Corporation
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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 3. Patient had final skin graft between 12-36 months prior enrollment in the study. 4. Burn must have been ≥10% total body surface area (TBSA) and ≤70% TBSA. 5. Patient is ≥ 21 years of age at the time of treatment.
Exclusion criteria
1. Patient had a radiation burn. 2. Patient was treated with Integra or BTM and closed via secondary intention. 3. Severe cognitive dysfunction or psychiatric disorders. 4. Immunocompromised patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from Integra or BTM treated burns to autograft procedure | 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). |
| Vancouver Scar Scale assessment of tissue quality | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of re-operations | 12-36 months post final skin graft application | Number of re-operations in burns treated with Integra vs burns treated with BTM |
| Number of re-admissions | 12-36 months post final skin graft application | Number of re-admissions in burns treated with Integra vs burns treated with BTM |
| Number of days in ICU | 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 |
| Percent of Integra or BTM 'take' | 12-36 months post final skin graft application | Percent of Integra or BTM 'take' in burns treated with Integra vs burns treated with BTM |
| Time from admission to Integra or BTM application | 12-36 months post final skin graft application | Time (number of days) from admission to Integra or BTM application to the burn |
| Autograft site details specifically associated with application of Integra or BTM on index injury | 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 |
| Length of Hospital Stays | 12-36 months post final skin graft application | Length of hospital stay in days following treatment of burns with Integra or BTM |
| Patient Survey Question regarding neuropathic pain | 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? |
| Tissue Pliability / Elasticity | 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. |
| Tissue Height | 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. |
| Tissue Density | 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. |
| Tissue Sensitivity | 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. |
| Patient-Observer Scar Assessment Scale (POSAS) | 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/ |
| Number of complications | 12-36 months post final skin graft application | Number complications (i.e. infection) in burns treated with Integra vs burns treated with BTM |
Outcome results
None listed