The Hemostatic Effectiveness of "HANBIO" Gauze During Non-emergent Gynecology Surgery.

HAN Biomedical

Status

Completed

Conditions

Hemostasis

Wounds and Injuries

Treatments

Device: "HANBIO" Gauze (Sterilized, 1% Collagen)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06715696

HAN2018001-CT01

Details and patient eligibility

About

The objective of this study is to collect the hemostatic effectiveness and device safety data of "HANBIO" Gauze in subjects have acute wound result from gynecology surgery.

Enrollment

40 patients

Sex

Female

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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 informed consent form.

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 as primary hemostasis.
Subject has participated in another clinical trial within the past 30 days.
Subjects with any pre-operative or intra-operative findings that may preclude conduct of the study procedure or unable to evaluate the outcomes.