The Influence of ARTISS on Post-operative Abdominal Drainage and Seroma Formation in DIEP/MS-TRAM Free Flap Breast Reconstruction Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- post-operative abdominal mean drainage duration
研究概览
简要总结
The Influence of ARTISS on post-operative abdominal drainage and seroma formation in DIEP/MS-TRAM free flap breast reconstruction patients.
详细描述
The principle aim of the study is to investigate the effect of ARTISS on abdominal wound drainage whether this could result in earlier drain removal and earlier patient discharge from hospital. The primary outcome investigated will be post- operative abdominal drainage duration in days which is vital information during this Covid pandemic to reduce hospital stay (and therefore possible Covid exposure) which could result in earlier discharge from hospital, as well as significantly reducing cost of the procedure to the NHS and frees in-patient beds for more efficient use of resources.
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)
盲法说明
Blinded patient and blinded assessor
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female adult (age 18-80)
- •Patients planned for immediate or delayed DIEP/MS-TRAM breast reconstruction
排除标准
- •Patients who are unable to consent or do not consent
- •Clotting disorder
- •Pregnancy
- •Individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).
- •COVID positive
- •Known previous allergic reactions to ARTISS
研究组 & 干预措施
without ARTISS
Surgery performed without active comparative
干预措施: no ARTISS (Other)
with ARTISS
Surgery performed with active comparative
干预措施: ARTISS 4mL Fibrin Sealant Topical Solution (Frozen) (Drug)
结局指标
主要结局
post-operative abdominal mean drainage duration
时间窗: 42 days
post-operative abdominal mean drainage duration
次要结局
未报告次要终点