Open, Blindly Evaluated, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Standard of Care in Accelerating the Healing of Grade 2a Partial-Thickness Burn Wounds
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 9
- 主要终点
- Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care
研究概览
简要总结
The main goal of this phase III clinical trial is to show safety and efficacy of Oleogel-S10 in the acceleration of wound healing of grade 2a burn wounds.
详细描述
Oleogel-S10 has shown efficacy and was well tolerated in previous clinical trials in patients with skin lesions. Especially the results in the split-thickness skin graft donor site, which is regarded as an excellent model for any kind of superficial wounds in human skin, suggest that Oleogel-S10 should be efficacious and safe in treatment of grade 2a burns.
The present Phase III clinical trial in grade 2a burns is initiated in order to measure the wound healing progress applying objective methods, i.e., the time to healing and the grade of epithelialization of the wound.
In this study, grade 2a burn wounds are separated into two halves: Following wound cleaning and disinfection, wounds are separated into two wound halves. Randomly assigned, one wound half receives Oleogel-S10 ointment, the other wound half standard of care treatment.
Wound healing progress is documented by photos which are assessed by expert reviewers blinded to the treatment of the wound halves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients at least 18 years old who have provided written informed consent.
- •Presenting with acute grade 2a burn wounds (as graded by an expert surgeon assisted by LDI or a multispectral imaging system) within 48 hours after injury.
- •Burn wound caused by fire burn, heat burn or scalding.
- •Burn patients with grade 2a burn wounds between 80 cm2 and less than 25% of their TBSA (alternatively, 2 comparable wounds with size more than 40 cm2 each and less than 12.5% of the TBSA each are allowed).
- •Patient is able to understand the Informed Consent Form provided and is prepared to comply with all study requirements, including the following: Visiting the trial site for wound dressing changes at least every second day (if patient is not hospitalized) and photo documentation until full wound closure or until the Investigator decides to change medication and/or treatment after day 21 after start of treatment
- •Willing to perform all necessary wound dressing changes at the trial site. Also the patient needs to agree to return to site for 3 and 12 months follow-up visits.
- •Women of childbearing potential must apply highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly (e.g., implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner))
排除标准
- •Suffering from chemical burns, or electrical burns or sunburns
- •Having already received treatment for their burn with silver sulfadiazine (obscures photographic wound evaluation).
- •Positive blood culture after the burn.
- •Diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerance or efficacy.
- •A skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
- •A history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
- •Known multiple allergic disorders.
- •Taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
- •Pregnant or breast feeding women are not allowed to participate in the study.
- •Inappropriate to participate in the study, for any reason, in the opinion of the Investigator.
- •Mental incapacity or language barriers precluding adequate understanding or co-operation or willingness to follow study procedures.
- •Previous participation in this study.
- •Employee at the investigational site, relative or spouse of the Investigator
研究组 & 干预措施
Oleogel-S10 ointment
Intra-individual comparison. Oleogel-S10 ointment is administered to one randomly assigned wound half.
干预措施: Oleogel-S10 ointment (Drug)
Oleogel-S10 ointment
Intra-individual comparison. Oleogel-S10 ointment is administered to one randomly assigned wound half.
干预措施: Octenilin® wound gel (Device)
Octenilin® wound gel
Intraindividual comparison: The other wound half receives disinfectant Octenilin® wound gel.
干预措施: Oleogel-S10 ointment (Drug)
Octenilin® wound gel
Intraindividual comparison: The other wound half receives disinfectant Octenilin® wound gel.
干预措施: Octenilin® wound gel (Device)
结局指标
主要结局
Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care
时间窗: 2 to 3 weeks
Photo-based evaluation by independent experts blinded to the treatment regime.
次要结局
- Time From Study Start After Burn Accident Until Wound Closure is Achieved Separately for Wound Halves Treated With Oleogel-S10 vs. Standard of Care(2 to 3 weeks)
- Intra-individual Difference in Time to Wound Closure Between Wound Halves, Either Treated With Oleogel-S10 or Treated With Standard of Care(2 to 3 weeks)
- Likert Scale Rating of Efficacy (Evaluated by Both the Investigators and Patients)(2 to 3 weeks)
- Cosmetic Outcome After 3 and 12 Months After Burn Accident, in Relation to Texture, Redness, Growth of Hair and Pigmentation, Based on Blinded Photo Evaluation(3 and 12 months)
- Likert Scale Rating of Tolerance (Evaluated by Both the Investigators and Patients)(2 to 3 weeks)
- Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator(2 to 3 weeks)
- PK Data: Systemic Presence/Concentration of Betulin in Blood Plasma Samples(2 to 3 weeks)
- Microbial Colonization of the Wound Halves(2 to 3 weeks)
- Assessment of Adverse Events(2 to 3 weeks)
- Percentage of Patients With Wound Closure at Different Time Points(2 to 3 weeks)