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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Wounds and Injuries Hemostasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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"HANBIO" Gauze

Group Type EXPERIMENTAL

"HANBIO" Gauze (Sterilized, 1% Collagen)

Intervention Type DEVICE

After tissue resection in a standard procedure for gynecological surgery, direct application of "HANBIO" Gauze to cover the bleeding site/area which identified during dissection.

Interventions

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"HANBIO" Gauze (Sterilized, 1% Collagen)

After tissue resection in a standard procedure for gynecological surgery, direct application of "HANBIO" Gauze to cover the bleeding site/area which identified during dissection.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No