Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468163
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-12
Brief Title:
Efficacy of Local Antibiotic Injection Via a Catheter for Treating Acute Periprosthetic Infections After Knee DAIR Surgery
Sponsor:
First Affiliated Hospital of Xinjiang Medical University
Organization:
First Affiliated Hospital of Xinjiang Medical University
Study Overview
Official Title:
Efficacy of Local Antibiotic Injection Via a Catheter for Treating Acute Periprosthetic Infections After Knee DAIR Surgery A Prospective Randomized Controlled Trial Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
YES
Brief Summary:
Prosthetic Joint Infection PJI is a severe complication following joint replacement surgery imposing significant economic and health burdens on patients For acute PJI the DAIR Debridement Antibiotics and Implant Retention procedure is a necessary and effective treatment method as it effectively clears the infection while preserving the prosthesis thereby avoiding more complex surgical interventions However the practice of using drainage tubes postoperatively is controversial Some studies suggest that drainage tubes may increase the risk of infection while other literature indicates no statistically significant difference in infection risk associated with their useIn this context Professor Li Caos team at Xinjiang Medical University has improved the traditional DAIR procedure by incorporating long-term local antibiotic injections post-surgery achieving positive results Despite this the specific method of antibiotic injection particularly whether to use a drug infusion tube remains under debate The use of an infusion tube can reduce patient discomfort shorten the local disinfection process and theoretically decrease the time the incision is exposed to the external environment potentially lowering the infection risk However the validity of these theoretical assumptions needs further confirmation through high-level scientific research This study aims to evaluate whether there are differences in joint function recovery changes in blood infection markers and the incidence of postoperative complications between using and not using an infusion tube for local antibiotic injection after knee DAIR surgery To assess the value of the infusion tube in local antibiotic injection post-knee DAIR surgery a randomized controlled trial RCT will be conducted Eligible patients will be randomly assigned to the infusion tube group experimental group or the non-infusion tube group control group The study will prospectively collect basic information joint function scores blood infection markers and postoperative complication data from both groups including patient age gender educational background and postoperative blood test results Ultimately the RCT aims to demonstrate the therapeutic efficacy of the infusion tube method
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None