A Multicenter Study to Assess the Safety and Performance of Surgiclot®
Research type
Research Study
Full title
A Multicenter Study to Assess the Safety and Performance of Surgiclot® in the Treatment of Cancellous Bone Bleeding
IRAS ID
163879
Contact name
Niall Craig
Contact email
Sponsor organisation
St Teresa Medical
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
The SurgiClot® study is a multi-centre prospective, non-randomised and open-label study, where up to 7 hospital sites will enrol a total of up to 40 subjects.
The primary objective of the study is to demonstrate the safety and performance of the SurgiClot® haemostatic dressing in the treatment of bone bleeding. Patients aged 18 and above who have provided written informed consent and are awaiting orthopaedic or spinal surgery will be enrolled,the total study duration for each subject will be approximately six weeks, in which the subjects will be required to attend 4 visits.
Blood loss during neurosurgical and orthopaedic surgery can be a source of significant morbidity and mortality. Therefore control of bone bleeding is of great importance, but the most effective approach remains unclear. This clinical study will determine if SurgiClot® is an effective haemostatic product for bone bleeding that, unlike other blood clotting products, will not leave a residue that could interfere with bone healing.
REC name
West of Scotland REC 4
REC reference
14/WS/1153
Date of REC Opinion
4 Feb 2015
REC opinion
Further Information Favourable Opinion