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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 主要终点
- Time from Integra or BTM treated burns to autograft procedure
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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.
结局指标
主要结局
Time from Integra or BTM treated burns to autograft procedure
时间窗: 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
时间窗: 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.
次要结局
- Length of Hospital Stays(12-36 months post final skin graft application)
- Number of complications(12-36 months post final skin graft application)
- Number of re-operations(12-36 months post final skin graft application)
- Number of re-admissions(12-36 months post final skin graft application)
- Number of days in ICU(12-36 months post final skin graft application)
- Percent of Integra or BTM 'take'(12-36 months post final skin graft application)
- Time from admission to Integra or BTM application(12-36 months post final skin graft application)
- Autograft site details 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)(12-36 months post final skin graft application)
- Patient Survey Question regarding neuropathic pain(12-36 months post final skin graft application)
- Tissue Pliability / Elasticity(12-36 months post final skin graft application)
- Tissue Height(12-36 months post final skin graft application)
- Tissue Density(12-36 months post final skin graft application)
- Tissue Sensitivity(12-36 months post final skin graft application)