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Evaluation of absorbable hemostatic fuid gelatin for intraoperative auxliary hemostasis: a prospective, multicenter, randomize d, parallel controlled, blinded assessment, non-inferiority clinical study

Evaluation of absorbable hemostatic fuid gelatin for intraoperative auxliary hemostasis: a prospective, multicenter, randomize d, parallel controlled, blinded assessment, non-inferiority clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113187
Enrollment
Unknown
Registered
2025-11-25
Start date
2021-11-19
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft tissue hemostasis

Interventions

Experimental Group:Administer Huanuo absorbable hemostatic fluid gelatin to assist hemostasis during surgery
Control group:Surgiflo absorbable hemostatic fluid gelatin is administered to assist hemostasis during surgery

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

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

MeasureTime frame
Effective rate of hemostasis within 5 minutes;

Secondary

MeasureTime frame
Effective rate of stopping bleeding in 3 minutes;Effective hemostasis time;

Countries

China

Contacts

Public ContactYueming Song

West China Hospital, Sichuan University

hx_sym@163.com+86 189 8060 1382

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026