Phase
Condition
Blood Clots
Treatment
"HANBIO" Gauze (Sterilized, 1% Collagen)
Clinical Study ID
Ages 20-70 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Female between 20 and 70 years of age.
Subject scheduled for a non-emergent, gynecological surgery.
Subject has an identified bleeding site/area intraoperatively.
Subject is willing to comply with all aspects of the study and have signed informedconsent form.
Exclusion
Exclusion Criteria:
Pregnant or lactating female.
The wound is chronic wound that not healed within 8 weeks, e.g. ulcers.
The wound is caused by radiation or burns.
Subject is sensitive or allergic to collagen.
Subject is sensitive or allergic to polyester (PET).
Subject has medical history of coagulation disorder or disease (e.g., hemophilia,thrombocytopenia).
Subject receives anticoagulants or antiplatelets.
Subject plans to receive other hemostatic gauze/dressing/agent/medical device asprimary hemostasis.
Subject has participated in another clinical trial within the past 30 days.
Subjects with any pre-operative or intra-operative findings that may precludeconduct of the study procedure or unable to evaluate the outcomes.
Study Design
Connect with a study center
National Taiwan University Hospital
Taipei,
TaiwanSite Not Available
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