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A non-inferiority, pre-marketing, randomized single-blind parallel controlled trial for absorbable bone wax

A non-inferiority, pre-marketing, randomized single-blind parallel controlled trial for absorbable bone wax

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033242
Enrollment
Unknown
Registered
2020-05-25
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-05-25

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

Conditions

Bone hemorrhage after bone operation

Interventions

Experimental group:absorbable bone wax
Control group:Johnson's Bone Wax

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: (1) Patients with bone hemorrhage after bone operation such as bone splitting, drilling and cutting; (2) 18-75 years old; (3)

Exclusion criteria

Exclusion criteria: (1) Those who are allergic to the ingredients of this product; (2) Those with bone infection; (3) Severe coagulation dysfunction; (4) Women who are breastfeeding or pregnant; (5) Those with severe heart, liver and lung diseases who are unable to tolerate treatment; (6) Those with ALT or AST greater than twice the normal value, those with abnormal creatinine; (7) Subjects participated in other clinical studies 3 months before enrollment; (8) The investigator believes that the patient is not suitable to participate in other situations of this study;

Design outcomes

Primary

MeasureTime frame
The effect of hemostasis within 3 minutes;

Countries

China

Contacts

Public ContactXianyou Zheng

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

zhengxianyou@126.com+86 13916180968

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 5, 2026