NCT02322710已完成不适用
Multicentre, Randomized, Parallel Group, Non-inferiority, Open-label Study Aiming at Comparing the Healing Rates (With Blinded Assessment Based on Photographs) of TULLEGRAS M.S.® With URGOTUL® in the Treatment of Surgical Acute Wounds.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 208
- 试验地点
- 67
- 主要终点
- Percentage of Patients With Complete Healing (100% of Epithelialization).
研究概览
简要总结
Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in the treatment of surgical acute wounds.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject.
- •Aged 18 to 75 years
- •With a planned surgery:
- •Of abdominal location
- •Leading to an acute wound of a maximum total length ≤ 18 cm (corresponding to 2 investigational products)
- •Absence of clinical sign suggestive of worsened wound (assessed only at the randomization visit)
- •Followed-up in surgery department
- •Written and signed informed consent obtained
- •Affiliated to the French Social Security system or equivalent.
排除标准
- •Underlying pathology that may interfere with wound healing in the opinion of the Investigator (human immunodeficiency virus [HIV], cancer, immunodeficiency disease, generalized infection, systemic disease ...). The presence of low-risk prostate cancer according to the Amico classification (1) (PSA<10 ng/mL and Gleason's score < 6 and clinical grade T1c ou T2a) or a grade T1 (a or b) N0M0 renal cancer which requires surgery without adjuvant therapy (radiotherapy, chemotherapy, hormonal therapy...), in a patient whose general condition is preserved without significant comorbidity or signs of malnutrition are not considered as a non- inclusion criteria
- •Inadequately controlled diabetes (Glycosylated hemoglobin > 8%)
- •Hypo or hyperthyroidism
- •Intake of a systemic treatment with glucocorticoids or immunosuppressives
- •Known allergy to one of study dressings components
- •Participation in a clinical trial in the month prior to his/her inclusion in the study
- •Pregnancy or breastfeeding or of childbearing potential and saying not to use contraception.
结局指标
主要结局
Percentage of Patients With Complete Healing (100% of Epithelialization).
时间窗: Day 21
Using photographs,independent assessor blinded assessment.
次要结局
未报告次要终点
研究者
研究点 (67)
Loading locations...
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SPOKE trialspoke injuries, bicycle spoke injuries, wound,NL-OMON24131Wintermans, S., Noordwest ziekenhuisgroepWilhelminalaan 121815 JD Alkmaars.wintermans@nwz.nl 072 - 548 4444108