NCT06608992

Evaluation of the Effect of SURGICEL® Powder in TKA

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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 (on postoperative days 3 and 5), intraoperative blood loss, transfusion rate and volume, postoperative hemoglobin decline, hematocrit decline, limb swelling rate (postoperative days 1-5), postoperative limb pain (measured by the Visual Analogue Scale, VAS, on days 1-5), and range of motion (ROM on days 1-5). 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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-28
• Primary completion: 2025-08-01
• Completion: 2025-09-01
• First posted: 2024-09-23
• Last updated: 2025-02-12

Locations

1 site across 1 country: China