DRKS00032643招募中Unknown
Wound healing promotion of teion plasma applications - Teion-Plasma
Teion Medizinprodukte GmbH0 个研究点目标入组 48 人开始时间: 2023年9月7日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Minimum age:
- •Maximum age:
- •No maximum age
- •Other inclusion criteria:
- •Age = 18 years (majority) and legal capacity - Wound for secondary wound healing after surgical intervention - Localisation: entire integument - Initial wound volume min. 2 cm3 - No exposed bone - No undermining, accessible for plasma treatment - Written informed consent from study participants. For female patients: Confirmed postmenopausal state (defined as amenorrhoea for at least 12 months) or for women of childbearing potential (WOCBP): Negative high sensitivity urine or serum pregnancy test prior to enrolment/randomisation and use of a highly effective contraceptive method (failure rate of less than 1%): - Combined (oestrogen and progestogen containing) hormonal contraception associated with ovulation inhibition (oral/intravaginal/ transdermal), or - Progestogen-only hormonal contraception, associated with ovulation inhibition (oral/injectable/implantable), or - intrauterine device, or - intrauterine hormone release system, or - bilateral tubal occlusion, or - vasectomised partner, or - heterosexual abstinence.
排除标准
- •Pregnant or breastfeeding, pacemaker or defibrillator, light/sun allergy, systemic/chronic infectious diseases (HIV, hepatitis, etc.). ), relevant tumour disease,ongoing chemotherapy or radiation, severe endogenous or drug immunosuppression, alcohol or drug abuse, dialysis requirement, oxygen requirement, wound infection, profuse bleeding wound, patients unwilling to consent to the storage and disclosure of pseudonymised medical data for study purposes, persons deprived of liberty under an official order or court order or authorisation, Persons who are in a dependent relationship with the sponsor, the investigator or the trial site are excluded from participation in the study, participation in another clinical trial according to the Medical Devices Implementation Act (MPDG)/Medical Devices Regulation (MDR) at the time of this study, participation in a therapeutic study (wound healing).
研究者
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