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CompletedNCT06715696Updated May 29, 2025

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

An interventional study of "HANBIO" Gauze (Sterilized, 1% Collagen) in Wounds and Injuries and Hemostasis, sponsored by HAN Biomedical Inc. Completed at 1 site in Taiwan. Open to female participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-29.

Sponsored by HAN Biomedical Inc · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
20 Years to 70 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Wounds and Injuries
  • Hemostasis

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03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 40 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

HAN Biomedical Inc is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    "HANBIO" Gauze

    Device: "HANBIO" Gauze (Sterilized, 1% Collagen)

Interventions

  • Device"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.

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. Number/proportion of adverse and serious adverse events.

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

    Time frame: 3 min

  3. 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

07

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06715696
Lead sponsor
HAN Biomedical Inc
Responsible party
Sponsor
First posted
Dec 4, 2024
Start date
Dec 15, 2024
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025
Last update
May 29, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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