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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
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.
Haemostatic device for the control of bleeding
Procedure for the control of bleeding
Bellvitge Hospital
Barcelona, Spain
achievement of haemostasis (yes/no).
visual observation of cessation of bleeding
Time frame: measured up to 10 minutes after application
Absence of re-intervention for post-operative bleeding
No return to OR for bleeding
Time frame: within 30 days of initial surgery
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