Clinical Hemostatic Effectiveness of PET-Collagen Gauze ("HANBIO" Gauze) for Acute Wound: a Prospective, Single-arm, Open-label Evaluation Study

HAN Biomedical Inc1 site in 1 country40 target enrollmentDecember 15, 2024

ConditionsWounds and Injuries Hemostasis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Wounds and Injuries
Sponsor: HAN Biomedical Inc
Enrollment: 40
Locations: 1
Primary Endpoint: Average Time(sec) to achieve hemostasis
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 15, 2024

End Date

March 31, 2025

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

HAN Biomedical Inc

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Average Time(sec) to achieve hemostasis

Time Frame: 3 min

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

Secondary Outcomes

Proportions of subjects achieving hemostatic success at 3 min.(3 min)
Number/proportion of adverse and serious adverse events.(3 min)
Ease of use questionnaire of Product "HANBIO" Gauze (by Principal Investigator)(3 min)