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OpenTrials
Completed

NCT Number: NCT06715696

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

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.

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Key information

Conditions

Wounds and Injuries Hemostasis

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"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.

Primary outcomes

  1. 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

  1. Proportions of subjects achieving hemostatic success at 3 min.

    Time frame: 3 min

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

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

    Time frame: 3 min

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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

HAN Biomedical Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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