Hemostasis, Wounds and Injuries
Conditions
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.
Interventions
DEVICEHANBIO 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.
Sponsors
HAN Biomedical Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Time(sec) to achieve hemostasis | 3 min | The mean time(seconds) required to achieve hemostasis following the application of HANBIO Gauze. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportions of subjects achieving hemostatic success at 3 min. | 3 min | Subjects achieved success hemostasis within or at 3 minutes following the application of HANBIO Gauze. |
| Number/proportion of adverse and serious adverse events. | 3 min | Subjects had AE or SAE following the application of HANBIO Gauze. |
| Ease of use questionnaire of Product HANBIO Gauze (by Principal Investigator) | 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. |
Countries
Taiwan
Outcome results
None listed