Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062484) titled 'A clinical trial evaluating whether oxidized regenerated cellulose reduces bleeding during and after bipolar hemiarthroplasty' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - No treatment

Primary Sponsor: Institute - The University of Osaka

Condition: Condition - Femoral neck fracture Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate whether the use of oxidized regenerated cellulose powder reduces perioperative blood loss compared with no use in patients undergoing bipolar hemiarthroplasty for femoral neck fracture. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - During bipolar hemiarthroplasty, after implant placement, 3 g of oxidized regenerated cellulose powder will be applied once to bleeding sites around the joint capsule in addition to standard hemostatic procedures, followed by gauze compression for 2 minutes. After hemostasis is confirmed, excess powder will be removed as much as possible. Tranexamic acid 1 g will be administered intravenously before surgery. Interventions/Control_2 - During bipolar hemiarthroplasty, oxidized regenerated cellulose powder will not be used. Standard hemostatic procedures will be performed, followed by gauze compression for 2 minutes after implant placement. Tranexamic acid 1 g will be administered intravenously before surgery.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Patients aged 20 years or older 2.Patients diagnosed with femoral neck fracture 3.Patients scheduled to undergo bipolar hemiarthroplasty at Ando Hospital 4.Patients for whom written informed consent is obtained from the patient or a legally acceptable representative1. Key exclusion criteria - 1.Patients with comorbid conditions associated with an increased bleeding tendency or severe coagulation disorders 2.Patients considered unsuitable for the use of oxidized regenerated cellulose powder 3.Patients considered unsuitable for participation in this study by the principal investigator or a study investigator Target Size - 130

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 05 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071508

Disclaimer: Curated by HT Syndication.