A Retrospective, Multi-Center Study Evaluating the Outcomes for Integra® Skin Sheet Bilayer or Single Layer Products Used in Complex Lower Extremity Soft Tissue Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 4
- 主要终点
- Wound recurrence rates after Integra application (and final split-thickness skin graft or dermoinductive agent application) as compared with free flap, local tissue flap, and negative pressure wound therapy.
研究概览
简要总结
This is a retrospective, multi-center study evaluating the outcomes of using Integra® skin sheet bilayer or single layer products for complex soft tissue reconstruction of lower extremity diabetic wounds compared to other treatments. Participating sites will collect information for all patients who received Integra, free flap, local tissue flap, or negative pressure therapy over a 5 year period. The patient must be a minimum of 1 year from index procedure, with index procedure being defined as the application of Integra, free flap, local tissue flap, or negative pressure. Any follow-up occurring during the year is eligible for inclusion.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
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
- •Diabetic (I or II) male or female, age greater than 18 years
- •Lower extremity wounds that required operative application of Integra, free flap, local tissue flap, or negative pressure wound therapy. Complex wounds are defined as wounds that involve exposed deep tissue (e.g. bone, tendon, fascia, ligament)
- •The patient must be a minimum of 1 year from the index procedure, any follow-up occurring during the year is eligible for inclusion.
排除标准
- •Age less than 18 years
结局指标
主要结局
Wound recurrence rates after Integra application (and final split-thickness skin graft or dermoinductive agent application) as compared with free flap, local tissue flap, and negative pressure wound therapy.
时间窗: 5 year period
A dermoinductive agent is a product that is said to promote rapid wound healing.
次要结局
- Time to ambulation/return to function after Integra application, free flap, local tissue flap, or negative pressure wound therapy.(5 year period)