Soft tissue hemostasis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients aged between 18 and 75 years old, regardless of gender; (2) Applicable to assist hemostasis in surgical operations; (3) Subjects can understand the purpose of the trial, voluntarily participate and sign the informed consent form;
Exclusion criteria
Exclusion criteria: (1) Patients with infection at the surgical site; patients undergoing ophthalmology, neurosurgery, or urology surgery; (2) Patients who use long-acting anticoagulants for a long time (except patients who have stopped taking long-acting anticoagulants for one week before surgery); (3) Patients with a history of allergy to gelatin or allergic constitution; (4) Patients with a critical condition where it is difficult to make an accurate evaluation of the effectiveness and safety of the device; (5) Patients who have used other hemostatic materials during surgery, such as gelatin sponge, cellulose materials, fibrin glue, or other hemostatic materials or drugs to achieve hemostatic effects; (6) Patients whose compliance is poor and who are unable to complete the study as required as judged by the investigator; (7) Women who are pregnant or have intended to become pregnant in the past year, or women who are breastfeeding; (8) Patients who have participated in other clinical trials in the past month; (9) Other patients who are judged by the investigator to be unsuitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of hemostasis within 5 minutes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective rate of stopping bleeding in 3 minutes;Effective hemostasis time; | — |
Countries
China
Contacts
West China Hospital, Sichuan University