EUCTR2011-005037-39-HU进行中（未招募）不适用
A Phase II Randomized, Controlled Parallel-Group Pilot Study to Assess the Safety and Efficacy of Kék Lukács Ointment Compared to Standard Silver Sulphadiazine (Dermazin®, SSD) Therapy in the Wound-healing of Patients With Deep Partial Thickness (Second-Degree) Burns - Clinical Trial of Kék Lukács Ointment in Treating Wounds
ukács és Társa Gyógyszerkereskedelmi Betéti Társaság0 个研究点开始时间: 2012年2月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent by the patient
- •2. Male and female patients aged between 18 and 65 years
- •3. Female patients with childbearing potential with a negative result from pregnancy test at inclusion, who agrees to use an acceptable birth control method (hormonal or IUD) or abstinence throughout the trial
- •4. Thermal origin burns
- •5. Total burn area for all burns on a single patient should be no greater than 15% of TBSA
- •6. Patients with burn injuries confined to the trunk and/or upper and lower extremities
- •7. Patients’ total study target burn area (second-degree) should be greater than
- •50 cm2 but no greater than 200 cm2 (or 1% of TBSA).
- •8. Patients with fresh (burn therapy started less than 24 hours post burn) second-degree burns (deep or mixed deep and superficial partial thickness burns).
- •9. Patients with non recent second-degree burns (burn therapy started later than 24 but not later than 36 hours post-burn).
- •10. Able to communicate well with the investigator and comply with the study requirements
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1. Patients with significant co-morbid conditions like chronic respiratory illness, ischemic or other cardiac disease and/or diabetes, immunodeficiency.
- •2. Patients with inhalation injury.
- •3. Burns >15% TBSA.
- •4. Patients with known or suspected allergy to any of the components of Kék Lukács ointment or SSD cream.
- •5. Head, genitalia, palms of hands, soles of feet and face are excluded as test sites.
- •6. Circumferential burns
- •7. Electrical and/or chemical burns.
- •8. Clinically significant systemic infections requiring systematic antibiotic treatment.
- •9. Patients with vascular or skin disorders that directly affect the designated wound site.
- •10. Any other acute or chronic concurrent medical conditions that in the Investigator’s opinion compromise study participation.
- •11. Lactation, pregnancy or women of childbearing potential not practicing an adequate method of contraception.
- •12. Participation in a clinical trial within 30 days before start of the trial.
- •13. History of drug and/or alcohol abuse.
研究者
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