NCT02417779已完成不适用
Effects of Extracorporeal Shock Wave Therapy in Cutaneous Microcirculation of Different Wounds
University Hospital Schleswig-Holstein2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2015年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Change in microcirculation (composite measure)
研究概览
简要总结
In plastic and reconstructive surgery, treatment strategies of second-degree burns, superficial wounds, hypertrophic burn scars, flaps and chronic wounds aim at reducing infection and improving microcirculation. Although previous studies indicate that extracorporeal shock wave therapy (ESWT) can accelerate wound healing, only a few studies focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of extracorporeal shock wave therapy on second-degree burns, superficial wounds, hypertrophic burn scars, flaps and chronic wounds in a human in-vivo setting for the first time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Group A (n=20): Consent-capable male and female patients ≥18 years of age who have sustained a second-degree burn on ≥1% and ≤30% of the surface of the body.
- •Group B (n=20): Consent-capable male and female patients ≥18 years of age who require a skin excision for the purpose of a skin graft. The minimal size of the skin-graft donor site must not be less than 1% of TBSA.
- •Group C (n=20): Consent-capable male and female patients ≥18 years of age suffering from a wound that has not yet healed ≥3 weeks. The minimal size of the wound site must not be less than 1% of TBSA.
- •Group D (n=20): Consent-capable healthy male and female probands ≥18 years of age serving as sham group. None of the the criteria of groups A-C must be evident. No soft tissue injury must be evident.
- •Group E (n=20): Consent-capable male and female patients ≥18 years of age who have sustained a second-degree burn on ≥1% and ≤30% of the surface of the body.
- •Group F (n=20): Consent-capable male and female patients ≥18 years of age who require a skin excision for the purpose of a skin graft. The minimal size of the skin-graft donor site must not be less than 1% of TBSA.
- •Group G (n=20): Consent-capable male and female patients ≥18 years of age suffering from a wound that has not yet healed ≥3 weeks. The minimal size of the wound site must not be less than 1% of TBSA.
- •Group H (n=20): Consent-capable healthy male and female probands ≥18 years of age serving as sham group. None of the the criteria of groups E-G must be evident. No soft tissue injury must be evident.
- •Group I (n=20): Consent-capable male and female patients ≥18 years of age suffering from a hypertrophic burn scar.
- •Group J (n=20): Consent-capable male and female patients ≥18 years of age suffering from a hypertrophic burn scar.
- •Group K (n=20): Consent-capable male and female patients ≥18 years of age who received a flap.
- •Group L (n=20): Consent-capable male and female patients ≥18 years of age who received a flap..
排除标准
- •General exclusion criteria
- •below 18 years of age
- •wounds requiring artificial respiration, since consent for the study participation is unobtainable
- •Exclusion Criteria Groups A, B, D, E, F, H:
- •peripheral arterial occlusive disease
- •vasculitis
- •diabetes mellitus
- •chronic kidney or liver disease
- •cardiac dysfunction
- •arterial hypo- or hypertension
- •Anamnestic exclusion criteria
- •ongoing immunosuppressive or chemotherapy treatment
- •drug abuse
- •systemic skin diseases
- •systemic and local cortisone therapy
结局指标
主要结局
Change in microcirculation (composite measure)
时间窗: Baseline and 1 minute post-dose
* capillary blood flow \[arbitrary units AU\] * capillary blood velocity \[AU\] * tissue oxygen saturation \[%\] * relative postcapillary venous filling pressure \[AU\]
次要结局
- Change in microcirculation (areolar measure)(Baseline, while and 1 minute post-dose)
研究者
Tobias Kisch
MD
University Hospital Schleswig-Holstein
研究点 (2)
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