Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06608992
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Evaluation of the Effect of SURGICEL Powder in TKA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Safety and Hemostatic Effectiveness of SURGICEL Powder in TKAa Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study subjects are patients in our hospitals 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 hospitals 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None