Gynaecology surgical procedures Surgery
Conditions
Interventions
Half the patients will be randomised to receive PerClot. The dose will be dependent on the surface area and will usually be 3G or 5G. The other half of the patients will be randomised to receive usual
Sponsors
CryoLife Europa (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Subject is over 18 2. Subject is having a gynaecological procedure 3. Subject is willing and able to comply with the protocol 4. Subject is willing and able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Subject with a history of pelvic or abdominal radiotherapy (within 8 weeks of surgery) 2. Subject is pregnant or actively breastfeeding 3. Subject has a ruptured ectopic pregnancy 4. Subject has a history of abnormal coagulopathy 5. Subject has a sensitivity to starch or starch derived materials 6. Subject has an active or potential infection at the surgical site 7. Subject is currently enrolled in another study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of haemostasis measured in minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Absence of reintervention for post operative bleeding | — |
Countries
Italy, Spain
Outcome results
None listed