Evaluation of Autologous Engineered Skin Substitute (ESS-W) Compared to Meshed, Split-Thickness Autograft (AG) for Treatment of Deep Partial- and Full-Thickness Thermal Burn Wounds in Adult Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Incidence and severity of infections at grafting sites
研究概览
简要总结
The purpose of this research study is to test how well the investigational treatment, Engineered Skin Substitutes (ESS-W), works for covering and treating burn wounds.
The areas of the body that are treated with ESS-W will be compared to similar areas treated with the patient's own skin (split-thickness skin autograft (AG)). A skin autograft (AG) will be performed by taking healthy skin from one area of the body and placing it on the burned area.
详细描述
This study is designed to evaluate the safety and efficacy of autologous engineered skin substitute (ESS-W) compared to conventional split-thickness AG for the treatment of extensive, deep partial- and full-thickness thermal burns. A matched and randomized burn site format will be used to evaluate the successful graft take on excised deep partial- and full-thickness burns when grafted with either 1) unmeshed ESS-W or 2) meshed AG (the current standard treatment of split thickness AG).
This research study is divided into five study periods: (1) Screening Period of up to one week and (2) Pre-Grafting Period, which will last approximately 35-45 days, (3) Grafting Day(s), which are the day(s) on which grafts are applied (i.e., First Graft: Day 0 and the optional subsequent Grafting Day i.e., Second Graft: Day 0), (4) Post Grafting Observation Period, which begins with 28 days follow-up after each Grafting Day(s), and continues till Post-Operative Month (POM) 6 from the last Grafting Day, and (5) Anecdotal Observation Period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has deep partial or full-thickness thermal burns ≥50% of the TBSA and fulfills the total grafting area requirement ranging from 288 cm2 up to 5,600 cm2, divided between two (or more) recipient sites.
- •Is expected to require multiple skin grafting procedures.
- •Is ≥18 years and ≤40 years of age at the time of enrollment.
- •Females of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use appropriate birth control methods during the pre-grafting period and for three months following the last Grafting Day.
- •Subject (or a legally authorized representative (LAR)) has provided written informed consent for study participation and procedures to be performed.
排除标准
- •Has a current diagnosis of septic shock or Multiple Organ Dysfunction Syndrome, which in the opinion of the Investigator would put the potential subject at risk of serious morbidity or death by participating in the study.
- •Has a current diagnosis of an invasive burn wound infection in unexcised burn wound.
- •Is pregnant.
- •Is a prisoner at the time of obtaining written informed consent.
- •Has a documented history of allergy or sensitivity to any of the antimicrobials or reagents used in preparation and application of ESS-W including the irrigation solution used before and after grafting. These include aminoglycosides, polymyxin B, mupirocin, ciprofloxacin, amphotericin B, hydrocortisone, and insulin.
- •Has a documented history of allergy or sensitivity to any of the animal products used in preparation of ESS-W. These products include bovine blood, bovine collagen, bovine collagenase, and porcine trypsin-versene.
- •Has a documented history of allergy or sensitivity to glycosaminoglycan, the polymer component of ESS-W.
- •Has a documented ongoing condition which could delay wound healing such as insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C).
- •Has a severe malnutrition or other concomitant illness which, in the opinion of the Investigator, has the potential to significantly delay wound healing.
研究组 & 干预措施
Treatment
All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG).
干预措施: Autologous Engineered Skin Substitute (Drug)
Treatment
All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG).
干预措施: Split-Thickness Autograft (AG) (Drug)
Control
All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG).
干预措施: Autologous Engineered Skin Substitute (Drug)
Control
All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG).
干预措施: Split-Thickness Autograft (AG) (Drug)
结局指标
主要结局
Incidence and severity of infections at grafting sites
时间窗: Up to Month 6 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 1 - Day 6, Day 7, Day 14 and Day 28 after each grafting day. * Post Operative Month 3 and Month 6 after the last grafting day.
Incidence of re-grafting
时间窗: Up to Month 6 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 7, Day 14 and Day 28 after each grafting day. * Post Operative Month 3 and Month 6 after the last grafting day.
Incidence of adverse events that are related to study treatment and associated with the grafting site
时间窗: Up to Month 36 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 1 - Day 6, Day 7, Day 14 and Day 28 after each grafting day. * Post Operative Month 3, Month 6, Month 12, Month 24 and Month 36 after the last grafting day
Incidence of all adverse events.
时间窗: Up to Month 36 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 1 - Day 6, Day 7, Day 14 and Day 28 after each grafting day. * Post Operative Month 3, Month 6, Month 12, Month 24 and Month 36 after the last grafting day
Percentage engraftment as determined by the Investigator through clinical assessment
时间窗: Up to Month 3 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 14 and Day 28 after each grafting day. * Post Operative Month 3 after the last grafting day
Percentage engraftment as determined by an independent observer through clinical assessment
时间窗: Up to Month 3 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 14 and Day 28 after each grafting day. * Post Operative Month 3 after the last grafting day
Percentage of wound closure as determined by blinded computerized planimetric assessment
时间窗: Up to Month 3 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 14 and Day 28 after each grafting day. * Post Operative Month 3 after the last grafting day
Percentage area of re-grafting as determined by blinded computerized planimetric assessment
时间窗: Up to Month 6 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 7, Day 14 and Day 28 after each grafting day. * Post Operative Month 3 and Month 6 after the last grafting day.
Confirmation of engraftment by histological assessment
时间窗: Up to Month 6 after the last grafting day
Assessments will be done on the following days/months: - Post Operative Month 3 and Month 6 after the last grafting day
次要结局
- Scar outcome assessment using the modified Vancouver Scar Scale (mVSS).(Up to Month 36 after the last grafting day)
- Incidence of increased temperature sensitivity(Up to Month 36 after the last grafting day)
- Incidence of contracture release or revision surgeries(Up to Month 36 after the last grafting day)
- Incidence of paresthesias, pain, dulling of sensation assessed through patient self-reporting scale and by monofilament testing(Up to Month 36 after the last grafting day)
- Incidence and severity of post-burn pruritus utilizing a validated patient self-assessment instrument(Up to Month 36 after the last grafting day)