The Hemostatic Effectiveness of "HANBIO" Gauze During Non-emergent Gynecology Surgery.
Clinical Hemostatic Effectiveness of PET-Collagen Gauze ("HANBIO" Gauze) for Acute Wound: a Prospective, Single-arm, Open-label Evaluation Study
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2024
CompletedFirst Posted
Study publicly available on registry
December 4, 2024
CompletedStudy Start
First participant enrolled
December 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedMay 29, 2025
May 1, 2025
4 months
November 28, 2024
May 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Average Time(sec) to achieve hemostasis
The mean time(seconds) required to achieve hemostasis following the application of "HANBIO" Gauze.
3 min
Secondary Outcomes (3)
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
Study Arms (1)
"HANBIO" Gauze
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2024
First Posted
December 4, 2024
Study Start
December 15, 2024
Primary Completion
March 31, 2025
Study Completion
March 31, 2025
Last Updated
May 29, 2025
Record last verified: 2025-05