PerClot Compared to Usual Care in Gynaecology Procedures
NCT ID: NCT02835391
Last Updated: 2017-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2015-11-30
2017-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PerClot
PerClot® Polysaccharide Hemostatic System (PerClot) is a medical device composed of absorbable polysaccharide particles (AMPs) and delivery applicators. Investigators will have the option to choose 3g or 5g dependent on the requirements of the patient
PerClot
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.
Usual Care
Usual care will consist of any other haemostat the Investigator would normally use in the control of bleeding i.e arista, Floseal, surgical, surgiflo. If the Investigator would not normally use a haemostat to control bleeding then electrocautery or diathermy may be used in this arm
Floseal, Surgicel, Surgiflo, Arista
Haemostatic device for the control of bleeding
Electrocautery/Diatermy
Procedure for the control of bleeding
Interventions
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PerClot
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.
Floseal, Surgicel, Surgiflo, Arista
Haemostatic device for the control of bleeding
Electrocautery/Diatermy
Procedure for the control of bleeding
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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CryoLife Europa
INDUSTRY
Responsible Party
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Locations
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Bellvitge Hospital
Barcelona, , Spain
Countries
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References
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Ponce J, Garcia-Tejedor A, Barahona M, Cappuccio S, Costantini B, Fedele C, Marti-Cardona L, Scambia G. Effectiveness and safety of an absorbable modified polymer starch powder hemostat versus usual care in gynecology procedures: A prospective, multi-center, and randomized study. PLoS One. 2025 Sep 11;20(9):e0331376. doi: 10.1371/journal.pone.0331376. eCollection 2025.
Other Identifiers
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PCT1501-000-C(01/15)
Identifier Type: -
Identifier Source: org_study_id
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