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RECRUITING
NCT06608992
PHASE4

Evaluation of the Effect of SURGICEL® Powder in TKA

Sponsor: Peking University Third Hospital

View on ClinicalTrials.gov

Summary

The study subjects are patients in our hospital's orthopedics department undergoing unilateral primary total knee arthroplasty (TKA) due to primary osteoarthritis. Through a prospective, parallel randomized controlled study, 112 participants will be divided into two groups: the SURGICEL® Powder group and the non-use group. The study will compare the total perioperative blood loss , intraoperative blood loss, transfusion rate and volume, postoperative hemoglobin decline, hematocrit decline, limb swelling rate , postoperative limb pain , and range of motion. Statistical analysis will be performed on the data to observe the hemostatic effects of SURGICEL® Powder, providing recommendations for the clinical use of SURGICEL® Powder.

Official title: Evaluation of the Safety and Hemostatic Effectiveness of SURGICEL® Powder in TKA:a Randomized Controlled Trial

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2024-09-28

Completion Date

2025-09

Last Updated

2025-02-12

Healthy Volunteers

No

Interventions

DRUG

SURGICEL® Powder

SURGICEL® Powder are hemostatic product made of compacted, regenerated oxidized cellulose fine fiber aggregates, produced using a patented process. These particles are pre-loaded into an applicator device for application to the target bleeding site. SURGICEL® Powder are white with a slight yellow tint and have a faint caramel-like scent.When SURGICEL® Powder are fully saturated with blood, they expand into a brown or black gel-like substance that helps form a blood clot. This substance acts as a hemostatic adjunct to control localized bleeding.

Locations (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China