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A randomized, open, parallel controlled, multicenter clinical trial to evaluate the effectiveness and safety of absorbable bone hemostatic materials in hemostasis of bone injury

A randomized, open, parallel controlled, multicenter clinical trial to evaluate the effectiveness and safety of absorbable bone hemostatic materials in hemostasis of bone injury

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058464
Enrollment
Unknown
Registered
2022-04-09
Start date
2022-04-06
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Bone injury

Interventions

Experimental group:Absorbable bone hemostatic material
Control group:Bone wax

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-80 years, gender is not limited; 2. Patients with osteoblending caused by osteotomy, drilling or bone cutting; 3. Patients who can understand the purpose of the trial, voluntarily sign an informed consent form, and can be followed up.

Exclusion criteria

Exclusion criteria: 1. Those who have participated in other clinical trials within 3 months before the start of the trial and have not completed other clinical trials; 2. Expected life expectancy of less than 3 months; 3. Infected bone damage surface; 4. Patients with coagulation dysfunction (specifically defined as 1.5 times the upper limit of PT or APTT) ; 5. Those who are pregnant, nursing or unable to use effective contraception and have a childbearing plan within 3 months; 6. Known allergies to this type of product; 7. The researchers judged that the patient's clinical condition was not suitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Hemostasis is effective within 3 minutes;

Secondary

MeasureTime frame
Incision healing time;Hemoglobin;Adverse Events;

Countries

China

Contacts

Public ContactYingang Zhang

Shaanxi Bai Ao Regenerative Medicine Co., Ltd

zyingang@mail.xjtu.edu.cn+86 29 85323930

Outcome results

None listed

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