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

Not Applicable

Recruiting

• Conditions: Wounds and Injuries; Hemostasis

• Registration Number: NCT06715696
• Lead Sponsor: HAN Biomedical Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2024-11-28
• Study First Posted: 2024-12-04
• Study Start: 2024-12-15
• Last Update Submitted: 2024-12-25
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Average Time(sec) to achieve hemostasis	3 min	The mean time(seconds) required to achieve hemostasis following the application of "HANBIO" Gauze.

Secondary Outcome Measures

Name	Time	Method
Proportions of subjects achieving hemostatic success at 3 min.	3 min	Subjects achieved success hemostasis within or at 3 minutes following the application of "HANBIO" Gauze.
Number/proportion of adverse and serious adverse events.	3 min	Subjects had AE or SAE following the application of "HANBIO" Gauze.
Ease of use questionnaire of Product "HANBIO" Gauze (by Principal Investigator)	3 min	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan