Cancer, Endometriosis, Menorrhagia, Ovarian Cyst, Uterine Fibroids
Conditions
Brief summary
This study is a post market, multi-centre, randomised study evaluating PerClot compared to usual care. PerClot is a CE marked device and is currently used as a haemostat in gynaecological surgery throughout Europe. The purpose of this study is to collect additional post market data on its use in this indication.
Detailed description
This study is a post market, multi-centre, randomised study evaluating PerClot compared to usual care. All subjects in this randomized study will undergo a laparoscopic or open gynecological procedure such as hysterectomy, cystectomy, myomectomy, endometrial excision or ablation. Subjects will be randomized to receive PerClot or usual care. This research will utilize a multi-center, prospective, randomized controlled study. The study will be conducted in2 study sites in Europe. An assumed sample of 90 subjects will be enrolled to evaluate the time to haemostasis. The enrollment of subjects to receive treatment will be based upon specific inclusion and exclusion criteria. Subjects will be randomized on a 1:1 basis to receive either PerClot or usual care. Data collected from both arms will be compared. Usual care will be at the discretion of the surgeon and may include any other haemostat or diathermy/electrocautery.
Interventions
DEVICEPerClot
Haemostatic device for the control of bleeding from capillary, venous or arteriolar vessels by pressure, ligature or other conventional means is either ineffective or impractical.
DEVICEFloseal, Surgicel, Surgiflo, Arista
Haemostatic device for the control of bleeding
PROCEDUREElectrocautery/Diatermy
Procedure for the control of bleeding
Sponsors
CryoLife Europa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is ≥ 18 years of age * Subject is undergoing gynecological procedure * Subject is willing and able to comply with the protocol and follow up period * Subject is willing and able to give written informed consent
Exclusion criteria
* • Subject with a history of pelvic or abdominal radiotherapy (within 8 weeks) * Subject is pregnant or actively breastfeeding * Subject has a ruptured ectopic pregnancy * Subject has a medical history of abnormal coagulopathy or bleeding * Subject has a sensitivity to starch or starch derived materials * Subject has active or potential infection at the surgical site * Subject is currently enrolled in another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| achievement of haemostasis (yes/no). | measured up to 10 minutes after application | visual observation of cessation of bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absence of re-intervention for post-operative bleeding | within 30 days of initial surgery | No return to OR for bleeding |
Other
| Measure | Time frame | Description |
|---|---|---|
| Absence of proven infection | within 30 days of initial surgery | No positive culture of blood results which indicate infection |
| Absence of bleeding related adverse events | within 30 days of initial surgery | No adverse events which are specifically caused by bleeding |
Countries
Spain
Outcome results
None listed