Functionality Assessments in Patients (Adults and Children) Following Treatment With Debrase Compared to Standard of Care (SOC) Protocol MW2012-12-12
试验速览
- 阶段
- 不适用
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Functionality evaluation using self reported questionnaires and ROM measurements
研究概览
简要总结
Once the victim survived the acute phase, the outcome of wound healing, the scarring, became a major medical issue with complications that may lead to cosmetic and functional sequelae. Scar tissue is clinically distinguished from normal skin by an aberrant color, rough surface texture, increased thickness (hypertrophy), contraction, firmness and sometimes, decrease function.
Thus, functional and cosmetic outcomes became at least important as wound closure in assessing wound healing products
详细描述
This is a multi-center, assessor-blinded study aiming to evaluate the long term functionality in adults and children who have participated in study MW2004-11-02 (previous phase 3 study).
We had previously shown that by using the MVSS scale which includes objective assessment of the physical characteristics of size, shape, volume, color, texture, and pliability as well as structural, mechanical and physiologic characteristics, lower (favorable) scores in Debrase vs. SOC group were observed in sub-groups of highly functional body parts of the hands and feet. This study will include specific functionality evaluation using the "Lower Extremity Functional Scale" test for burns in the lower extremities and the "QuickDASH" outcome measure for burns in the upper extremities as well as range of motion measurements of the joints (knee, ankle, shoulder, elbow and wrist, as relevant).
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 61 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults and children who had participated and completed study MW2004-11-
- •Patients must be able to sign and dated written informed consent prior to study entry (by Patient or by a guardian, when applicable).
排除标准
- 未提供
结局指标
主要结局
Functionality evaluation using self reported questionnaires and ROM measurements
时间窗: 2-5 years following to acute treatment
Functionality evaluation of wounds that have been treated by Debrase or SOC during the previous phase 3 study by: 1. Self-report questionnaires designed to measure physical function: the "Lower Extremity Functional Scale" test for burns in the lower extremities and the "QuickDASH" outcome measure for burns in the upper extremities. 2. Range of motion measurements of the following injured joints: knee, ankle, shoulder, elbow, wrist palm and fingers, as relevant.
次要结局
未报告次要终点