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

HAN Biomedical Inc40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Wounds and Injuries Hemostasis

Interventions

"HANBIO" Gauze (Sterilized, 1% Collagen)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.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Average Time(sec) to achieve hemostasis

The mean time(seconds) required to achieve hemostasis following the application of "HANBIO" Gauze.

Time frame: 3 min

Secondary Outcomes

Proportions of subjects achieving hemostatic success at 3 min.

Subjects achieved success hemostasis within or at 3 minutes following the application of "HANBIO" Gauze.

Time frame: 3 min

Number/proportion of adverse and serious adverse events.

Subjects had AE or SAE following the application of "HANBIO" Gauze.

Time frame: 3 min

Ease of use questionnaire of Product "HANBIO" Gauze (by Principal Investigator)

Five questions regarding conveniency, non-adhesive property, conformability and hemostatic efficacy of "HANBIO" Gauze will be evaluated by surgeon(PI). One description, from "very satisfied", "satisfied", "neutral", "unsatisfied", "very unsatisfied", will be selected for each question.

Time frame: 3 min

Data from ClinicalTrials.gov

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