Wounds and InjuriesNCT06715696
The Hemostatic Effectiveness of "HANBIO" Gauze During Non-emergent Gynecology Surgery.
A study testing "HANBIO" Gauze (Sterilized, 1% Collagen) in people with Wounds and Injuries and Hemostasis, run by HAN Biomedical Inc at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Wounds and Injuries, Hemostasis
- What is being tested?
- "HANBIO" Gauze (Sterilized, 1% Collagen)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Dec 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Hemostatic Effectiveness of PET-Collagen Gauze ("HANBIO" Gauze) for Acute Wound: a Prospective, Single-arm, Open-label Evaluation Study
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.
- Conditions
- Wounds and Injuries, Hemostasis
- Being tested
- "HANBIO" Gauze (Sterilized, 1% Collagen)
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"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.
| Study group | Role | What they receive |
|---|---|---|
| "HANBIO" Gauze | Experimental | Not described Receives: Device: "HANBIO" Gauze (Sterilized, 1% Collagen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Time(sec) to achieve hemostasis
The mean time(seconds) required to achieve hemostasis following the application of "HANBIO" Gauze.
Measured: 3 min
Secondary outcomes (3)
Proportions of subjects achieving hemostatic success at 3 min.
Subjects achieved success hemostasis within or at 3 minutes following the application of "HANBIO" Gauze.
Measured: 3 min
Number/proportion of adverse and serious adverse events.
Subjects had AE or SAE following the application of "HANBIO" Gauze.
Measured: 3 min
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.
Measured: 3 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start15 Dec 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- HAN Biomedical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715696
- Sponsor's protocol ID
- HAN2018001-CT01
- Status last verified
- May 2025
- First submitted
- 28 Nov 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Hemostatic Effectiveness of PET-Collagen Gauze ("HANBIO" Gauze) for Acute Wound: a Prospective, Single-arm, Open-label Evaluation Study
- ClinicalTrials.gov ID
- NCT06715696
- Acronym / sponsor ID
- HAN2018001-CT01
- Conditions
- Wounds and Injuries, Hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- HAN Biomedical IncIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "HANBIO" Gauze | Experimental | Device: "HANBIO" Gauze (Sterilized, 1% Collagen) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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. | Device | "HANBIO" Gauze |
Primary outcome
Average Time(sec) to achieve hemostasis
Time frame: 3 min
The mean time(seconds) required to achieve hemostasis following the application of "HANBIO" Gauze.
3 secondary outcomes
Proportions of subjects achieving hemostatic success at 3 min.
Time frame: 3 min
Number/proportion of adverse and serious adverse events.
Time frame: 3 min
Ease of use questionnaire of Product "HANBIO" Gauze (by Principal Investigator)
Time frame: 3 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
Related trials for Wounds and Injuries
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "HANBIO" Gauze (Sterilized, 1% Collagen) in people with Wounds and Injuries and Hemostasis, run by HAN Biomedical Inc at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Time(sec) to achieve hemostasis (time frame: 3 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.