NCT02417818已完成不适用
Effects of Plasma 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, burn scars, flaps and chronic wounds aim at reducing infection and improving microcirculation. Although previous studies indicate that Plasma Therapy 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 Plasma Therapy on second-degree burns, superficial wounds, 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
- Treatment
- 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 wound.
- •Group J (n=20): Consent-capable male and female patients ≥18 years of age suffering from a hypertrophic burn wound.
- •Group K (n=20): Consent-capable male and female patients ≥18 years of age received a flap.
- •Group L (n=20): Consent-capable male and female patients ≥18 years of age 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)
Loading locations...
相似试验
已完成
不适用
Cutaneous Microcirculation After Extracorporeal Shock Wave TherapyBurn InjuryAcute WoundChronic WoundBurn ScarFlap DisorderNCT02417779University Hospital Schleswig-Holstein240
招募中
2 期
Plasma On chronic Wounds for Epidermal Regeneration - Randomized, controlled clinical trial to investigate the efficacy of plasma therapy for the treatment of chronic, non-healing wounds in comparison to standard wound therapyI83.0I70.24L97L98.4Varicose veins of lower extremities with ulcerUlcer of lower limb, not elsewhere classifiedChronic ulcer of skin, not elsewhere classifiedDRKS00019943Coldplasmatech GmbH167
已完成
不适用
Wound-healing Improvement by Resurfacing Split-Thickness Skin Donor Sites With Thin Split-thickness GraftingSkin Graft DisorderDisorder of Skin Donor SiteWound Healing Disturbance ofNCT01974583Tang-Du Hospital192
招募中
Unknown
Wound healing promotion of teion plasma applicationsT89.03DRKS00032643Teion Medizinprodukte GmbH48
招募中
不适用
Trial of Different Wound Dressings in Split-skin Grafted Third Degree BurnsSplit-skin Grafted Third-degree Burn WoundNCT03674151University Hospital Schleswig-Holstein20