A Prospective, Multicenter, Randomized, Controlled, Non-Inferiority Clinical Trial to Evaluate the Efficacy and Safety of Absorbable Bone Wax in Pediatric Patients Undergoing Bone Hemostasis.

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Experimental Group:Intraoperative hemostasis of bone wounds, using absorbable bone wa Xfor children.;Control Group:Intraoperative hemostasis of bone wounds, using BoneWax.; CONDITION: Pediatric patients requiring hemostasis for bone surfaces PRIMARY OUTCOME: Hemostasis efficacy within 3 minutes; SECONDARY OUTCOME: Adverse events and serious adverse events (AEs and SAEs);Bone healing rate;Device defect;Device performance evaluation;Amount of bone wa Xused;Bone wa Xextrusion rate;Complications: granuloma, infection, postoperative secondary bleeding or hematoma, subcutaneous effusion, poor incision healing, etc.;Number of bone wa Xapplications;Incision Grade I healing rate;Average effective hemostasis time; INCLUSION CRITERIA: 1. Aged between 2 and 18 years, regardless of gender. 2. Pediatric patients with bone wounds requiring hemostasis. 3. Sign the informed consent form as required.
Epistemonikos ID: bffacef4cf84358e5f77cb1dd0f16d09585e26c3
First added on: Oct 08, 2026