Der Einsatz Von SUPRATHEL 250 Als Neuartige Therapeutische Option in Oropharyngealen Defekten. // The Use of SUPRATHEL 250 as a Novel Therapeutic Option for Oropharyngeal Defects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain Intensity (VAS)
研究概览
简要总结
To assess the use of Suprathel 250 for mucosal reconstruction in oropharyngeal defects. The membrane will be applied after tonsillectomy procedures and compared to bare wounds' healing
详细描述
After tonsillectomy procedures, the wound is usually left bare to heal. This causes severe pain postoperatively and postoperative hemorrhage. Suprathel 250 is a synthetic biodegradable PLA membrane which is proven as a skin membrane in burn wounds with excellent result. We therefore hypothesize that the use of Suprathel 250 after tonsillectomy procedures will allow for faster , less painful healing of the wound bed which allows for a better quality of life for the patients.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Indication for tonsillectomy according to the applicable clinical guideline.
- •Male or female patients aged 18 years or older.
- •Ability to understand the study information and provide written informed consent.
排除标准
- •pregnant/ breastfeeding women
- •patients undergoing chemo / radiotherapy
研究组 & 干预措施
Study group
The wound bed is left bare after the tonsillectomy procedure
干预措施: Comparator (Other)
Suprathel 250 group
The SupraTHEL 250 membrane is sutured onto the wound bed after the tonsillectomy procedure
干预措施: Suprathel 250 (Device)
结局指标
主要结局
Pain Intensity (VAS)
时间窗: postoperative day 0, 1, 2, 3, 4, 5, 7 and 10
Visual Analogue Scores (0-10; 0 lowest , 10 highest)
次要结局
- Secondary Study Endpoints in Tonsillectomy Patients(Screening -- until 10 days Postoperative)
研究者
Alaa Emara
Associate Professor
Cairo University