The Surgical Powder EU PMCF Study

• Research type

  Research Study

• Full title

  A Prospective, Clinical Study Evaluating the Safety and Haemostatic Effectiveness of SURGICEL®/TABOTAMP® Powder, Absorbable Haemostatic Powder (oxidized regenerated cellulose) in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding during General, Gynaecological, Urological, and Cardiothoracic Surgery in Adult Subjects

• IRAS ID

  244998

• Contact name

  Nawwar Al Attar

• Contact email

  nawwar.al-attar@gjnh.scot.nhs.uk

• Sponsor organisation

  Ethicon Inc.

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  A single arm study to evaluate the safety and effectiveness of SURGICEL Powder in controlling mild or moderate bleeding during surgery in adults. The study is being conducted as a result of a regulatory request from BSI and will recruit 100 patients at sites in Belgium and the UK. The sponsor and funder of the study is Ethicon Inc.

• REC name

  West of Scotland REC 3

• REC reference

  18/WS/0118

• Date of REC Opinion

  20 Sep 2018

• REC opinion

  Further Information Favourable Opinion