Open-Label, Controlled, Randomized, Comparative, Dose Escalation Study Of The Safety, Human Immunology, And Efficacy Of StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects In Patients Undergoing Sequential Skin Reconstruction Procedures
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Percent Autograft Take on Wounds Prepared by StrataGraft™ Skin Tissue.
研究概览
简要总结
This pilot Phase I/II clinical study will be conducted at up to three clinical sites.
This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients, each with skin defects. The patients are intended to undergo sequential surgical procedures involving surgical skin debridement and temporary allogeneic (cadaver skin) grafting at various separate or contiguous wound sites. Patients will be randomized within each wound site to one of two test products: cadaver skin or StrataGraft™ skin tissue.
详细描述
Stratatech has completed a phase I/IIa clinical study to assess the safety and efficacy of escalating amounts of StrataGraft skin tissue in patients with complex skin defects requiring sequential debridement and temporary wound coverage with biological dressing prior to autografting. The specific objectives of this phase I/IIa clinical trial were to assess the safety of StrataGraft skin tissue using a predetermined panel of clinical and laboratory endpoints and assess the efficacy of StrataGraft skin tissue by comparing the ability of StrataGraft skin tissue to the standard of care, human cadaver skin, to condition complex skin defects for subsequent autografting. In three cohorts of five patients each, the maximum amount of StrataGraft skin tissue applied to excised full-thickness skin wounds was increased sequentially from 0.5% to 1.0%, and then to 1.5% TBSA. Equivalent study wound areas on each subject were treated with StrataGraft or cadaver allograft for one week, at which time the allograft tissues were removed and the wound bed was evaluated. Infection and appearance of the temporary allogeneic skin tissue were evaluated at every study session until autograft placement. The wound was covered with split-thickness skin autografts when the wound was judged ready to accept an autograft. Autograft take was assessed two weeks after autograft placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged greater than 18 yrs.
- •Patients with complex skin defects requiring sequential debridement under anesthesia with temporary biological dressing (allogeneic grafting) prior to autografting
- •Full-thickness skin defects
- •Informed consent
排除标准
- •Prisoners
- •Pregnant (positive urinary pregnancy in women of child-bearing potential at Visit#1) or lactating females
- •Immunosuppressive therapy
- •Infection with Human Immunodeficiency Virus
- •Venous stasis ulcers of the lower leg
- •Diabetic foot ulcers
- •Donor site wounds
- •Wounds of less than 5% body surface area
- •Wounds of the hands, face, and feet (although such wound surface areas can be counted toward total injured BSA)
- •Prior entry into this study
- •Expected survival of less than 3 months
- •Concomitant processes sustained contemporaneously with the dermal injury (e.g., inhalational injury requiring ventilation, electrical injury with cardiac damage or arrhythmia, sepsis, other serious or unstabilized organ damage from trauma, etc.)
- •Use of an investigational agent within 30 days
- •Active malignancy
- •Clinical evidence of malnutrition
- •Clinically significant renal, hepatic, cardiac, pulmonary, or neurological impairments
研究组 & 干预措施
StrataGraft : cadaver allograft
All patients enrolled received StrataGraft skin tissue and an intrapatient control area treated with cadaver allograft in a split-wound design
干预措施: StrataGraft Skin Tissue (Biological)
StrataGraft : cadaver allograft
All patients enrolled received StrataGraft skin tissue and an intrapatient control area treated with cadaver allograft in a split-wound design
干预措施: Cadaver allograft (Procedure)
结局指标
主要结局
Percent Autograft Take on Wounds Prepared by StrataGraft™ Skin Tissue.
时间窗: two weeks post-autografting
The percentage take of the autografted area on each treatment site based on clinical judgement of visual and tactile assessments two weeks after autografting of wounds that had been temporarily covered with StrataGraft skin tissue.
次要结局
- Appearance of Allograft Tissues(StrataGraft and cadaver allograft appearance were performed every other day after placement and at the time of allograft removal and the values averaged for each subject.)
- Viability of Allograft Tissues(At the time of allograft removal (~7 days))