Treatment of haemorrhage in surgical patients Surgery
Conditions
Interventions
A novel haemostat using only a physical modification of the device surface to affect adhesion was evaluated by multiple surgeons, across 6 surgical specialities. A structured questionnaire relating to
Sponsors
Selentus Science
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patient undergoing elective surgery 2. Patient greater than 16 years of age 3. Able to give informed consent 4. Willing to complete study procedures and attend for follow-up visit
Exclusion criteria
Exclusion criteria: 1. Presence of a documented disorder of coagulation 2. An INR >2.0 within 12h of surgery (if measured) 3. Allergy to porcine products 4. Use of dual anti-platelets within 3 days of surgery 5. Oral anti-coagulant use within 24h of surgery 6. Enrolment in another clinical study that might reasonably interfere with this study’s end-points 7. Member of a vulnerable group of adults or life expectancy less than one year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effectiveness of haemostasis graded from 1 (unacceptable) to 5 (excellent) by the operating surgeon at the end of the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The effectiveness of adhesion graded from 1 (unacceptable) to 5 (excellent) by the operating surgeon at the end of the procedure. 2. The ease of use of the haemostat graded from 1 (unacceptable) to 5 (excellent) by the operating surgeon at the end of the procedure. 3. Binary response to whether the surgeon would use the product again during surgery | — |
Countries
Belgium, Croatia, Denmark, England, France, Germany, Netherlands, Serbia, Sweden, United Kingdom
Contacts
Public ContactPaul Hayes
Outcome results
None listed