DRKS00006178进行中（未招募）4 期
Wound Management in Post-Bariatric SurgeryInvestigation for the reduction of the mean drainage volume in patients after abdominoplasty / lower body lift using Artiss Fibrin Sealant in comparison to the standard procedure - WMPS
niversität Leipzig0 个研究点目标入组 20 人开始时间: 2014年5月20日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •age of 18 to 65 years
- •- Previous bariatric surgery with reaching an equilibrium plateau over 6 months
- •- planned abdominoplasty / lower body lift
- •- estmated resection weight >1 kg
- •- Written informed consent
排除标准
- •- inoperable from anaesthesiological perspective
- •- increased bleeding tendency (ProTime INR<= 70%; PTT >= 38 sec; platelets <= 150.000/mm³)
- •- instable diabetes mellitus typ II (HbA1c >8%)
- •- known complications after blood transfusion (especially AB0 incompatibility reaction, Rh incompatibility reaction)
- •- known hypersensitivity to human fibrin, aprotinin, human thrombin, L-histidine, niacinamide
- •- Women during pregnancy and lactation (positive pregnancy test in women of childbearing age)
- •- Participation in other clinical trials
研究者
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