NCT01330407Unknown3 期
Comparative Assessment of Adjuvant Effect of Cultured Epidermal Autografts Versus Skin Allografts on Wound Healing of Burns Treated With Widely Expanded Skin Autograft Using Meek Micrografting Technique MEEKADEAU
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- TIME OF HEALING
研究概览
简要总结
The investigators intend to conduct a comparative, monocentric prospective double-blind study with intra-subject randomization, to compare the results on wound healing of 2 adjuvant treatments to Meek micrografting technique : Cultured Epidermal Autografts and cryopreserved skin allografts.
详细描述
10 patients presenting burn wounds over 50% of total body surface area, including at least 40 % of deep burns, will be enrolled.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 18 to 60 years of age
- •Burns > 50% Total Body Surface Area (TBSA), including deep burns > 40% TBSA (deep partial thickness and full thickness burns).
- •Patients presenting two 300 cm² (30x10cm) non adjacent burn wound areas, of similar depth assessed by Laser Doppler Imaging, on body anterior side, functional areas excepted.
- •Written informed consent, signed by patient or legal representative (if patient unable to sign).
- •Negative pregnancy test
排除标准
- •Chemical or electric burns
- •Short delay life threatening disease, by itself or when associated with burns.
- •Chronic systemic steroïd intake,
- •Pre-existing diseases interfering with wound healing : inherited connective tissue disorder (Ehlers Danlos syndrome, Marfan syndrome), Epidermolysis Bullosa. Medical treatment interfering with wound healing (retinoids..).
- •Pregnant women
- •Patient under guardianship.
- •Participation in another investigational trial within this trial
研究组 & 干预措施
gp2
Experimental
Cultured Epidermal Autografts
干预措施: Cultured Epidermal Autografts (Procedure)
gp1
Active Comparator
cryopreserved skin allografts.
干预措施: cryopreserved skin allografts. (Procedure)
结局指标
主要结局
TIME OF HEALING
时间窗: 2 YEARS
to compare wound healing speed on the 2 treated areas, considering epithelialization rate until complete wound healing.
次要结局
- QUALITY OF HEALING(2 YEARS)
研究者
研究点 (2)
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