C.Surgical Procedure; Cardiac, Haemorrhage.
Conditions
Brief summary
The effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to Floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac and aortic thoracic surgery.
Interventions
DEVICE032-11
Topical haemostat
DEVICEFloseal (R)
Topical haemostat
Sponsors
The Clinical Trial Company
Medtrade
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must be equal or greater than 18 years old * The patient must have elective or non-elective urgent cardiac surgery or thoracic aortic surgery * The patient must have no childbearing potential or have a negative serum or urine pregnancy test within 7 days of the planned surgery or in the opinion of the Investigator performs adequate contraception * The patient is willing and able to be contacted for the follow-up visit at 6- 8 weeks * The patient must provide written informed consent using a form that is reviewed and approved by the IEC
Exclusion criteria
* The patient is currently enrolled in this or another investigational device or drug trial that has not completed the required follow up period. * The patient has a known hypersensitivity to materials of bovine origin * The patient does not wish to receive materials of bovine or shellfish origin for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haemostasis success | Intra-operative | Proportion of patients achieving haemostasis success following the first application of compression. |
Countries
United Kingdom
Contacts
Primary ContactSara Farmer
Backup ContactJune Gladman, PhD
Outcome results
None listed